Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which were incompletely irradiated, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..
Blood products, collected from a donor who was in close contact with an individual diagnosed as a  hepatitis B carrier,  were distributed..
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
White Farm Enriched White Bread. 16 oz (454g), 9pc/box.  UPC 0 10314 10002 0.     The label is white with blue and green lettering and red design accents.  The LL Bakery Logo is on the bottom left corner.
LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements.
Butter Farm Enriched White Bread 16 oz (454g), 9pc/box.  UPC 0 10314 10004 4.      The label is white with blue and green lettering and red design accents.  The LL Bakery Logo is on the bottom left corner.
Italian Cream Danish 8.5 oz (240g), 14pc/box.  UPC 0 10314 40056 4.     The pastry is braided and has yellow creamy swirls and sliced almonds.  The label is white with black lettering and a tan colored border.  The LL Bakery Logo is on the bottom left corner.
Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)
Plastic bottle containing 10.5 mL of IgG Conjugate     Product Usage:   Product is a used as a counterstain for various indirect fluorescent assay kits
Product Code: CCG-9912;      Lot: CCG-0280
Affected products have a labeled expiration date of one year too long.
Plastic bottle containing 10.5 mL of IgM Conjugate     Product Usage:   Product is a used as a counterstain for various indirect fluorescent assay kits
Product Code: CCM-9914;      Lot: CCM-0281
Plastic bottle containing 3.5 mL of IgG FITC Conjugate     Product Usage:   Product is a used as a counterstain for various indirect fluorescent assay kits
Product Code: CCG-9972;      Lot: CCG-0281
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant,  Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
AMBI 20DM100GFN10PEH, Antitussive,  Expectorant,  Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
AMBI 25DPH/7.5PEH, Antihistamine,  Nasal Decongestant,  Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16
AMBI 12.5 CPD/100GFN/30PSE, Antitussive,  Expectorant,  Nasal Decongestant,  Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant,  Expectorant,  Nasal Decongestant,  Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16
AMBI 25CPD/200GFN, Antitussive,  Expectorant,  Berry Vanilla  Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
AMBI 2CPM/15DM/5PEH, Antihistamine,  Nasal Decongestant,  Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
AMBI 3BRM/15DM/30PSE,  Antihistamine,  Cough Suppressant,  Nasal Decongestant,    Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
AMBI 3BRM/30DM/50PSE, Antihistamine,  Cough Suppressant,  Nasal Decongestant,    Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
AMBI 40PSE/400GFN/20DM,  Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
ED A-HIST TABLETS,  Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
31,739 bottles 100-count; 842,617 Bulk tablet bottles
Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01
8296 bottles  - 100-count and 153,028 Bulk tablets
BROMPHENIRAMINE/PSEUDOEPHEDRINE  DM, LIQUID,    Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30
Cardec DM Drops,  Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604,  NDC 58605-0408-01
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
BroveX PSE DM, Antihistamine, Cough Suppressant,   Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737    NDC 58605-441-01
BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01  b) 20 ml NDC 58605-150-02,  Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
57,936 bottles - 20 mL and 7,476  bottles -16 ounce
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01  b) 20 ml NDC 58605-151-02,  Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
Lusair Liquid, 1 PINT bottle, OTC, Marketed by:  Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16
Poly Hist Forte, Nasal Decongestant, Antihistamine,  100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604  NDC 29273-0706-10
CPM / PSE Drops, Antihistamine, Nasal  Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30
CPM / PSE DM Drops, Antihistamine, Cough Suppressant  Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
Mesehist DM,  Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872     NDC 13811-0085-16
Mesehist WC,  Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16
TL-DEX DM,  Cough Suppressant  Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872,      NDC 13811-068-16
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
Trigofen DM Drops,  Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872,  NDC 13811-0082-30
Z-Dex Pediatric Drops, Cough Suppressant  Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872,     NDC 13811-0001-30
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872     NDC 13811-0073-16
Nationwide and Puerto Rico, and Panama.  Military distribution made.
Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal,  Novartis Consumer Health, Inc., Parsippany, NJ.      (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42;    (b) 12 gm  (.42 oz), packaged with UPC code:  300673998124 and NDC code: 0067-3998-12;   (c) 30 gm  (1 oz), packaged with UPC code:  300673998308 and NDC code: 0067-3998-30;   (d) 30 gm  (1 oz), packaged with UPC code:  300673998339 and NDC code: 0067-3998-33.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal),  a) 12 g (.42 oz) Tube, NDC 0067-3999-12,  Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121,  (Vertical Pack) and b)  packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code:  300673999428.
Lot number and exp date:  10104145  30-Apr-2013. (Vertical package) and Lot number and exp date:  10109587  30-Apr-2013, 10111508  31-May-2013; 10119095 31-Jul-2013 and 10119096  30-Sep-2013 (Horizontal package).
The products have illegible lot and/or expiration dates on the product container.
Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box,  Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438.  (Club Pack), NDC 0067-6295-43
Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405),  Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.
Lifesouth Community Blood Centers, Inc. - Mobile Region
Blood product, which did not meet acceptable product specifications, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, labeled with an incorrect expiration dates, were distributed.
Community Blood Centers of South Florida, Inc.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed.
Community Blood Centers of South FL, Inc.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
American Red Cross Blood Svs. Indiana-Ohio Region
Blood product, with platelet yield below the specified minimum requirement, was distributed.
Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.
Blood products, collected from a donor who had not had an annual physical performed, were distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
West Tennessee Regional Blood Center Inc
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was  distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Inova Health Care Services, Inova Blood Donor Services
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood Products, collected from an ineligible donor, were distributed.
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.
SlingBar 350.     Designed to meet the needs for lifting humans.
Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom  is requesting products be removed from field use and   replaced with an updated design.
SlingBar 360.     Designed to meet the needs for lifting humans.
SlingBar Wide 670.      Designed to meet the needs for lifting humans.
SlingBar Standard.     Designed to meet the needs for lifting humans.
Blood product, collected from a donor with risk factors for vCJD, was distributed.
Blood products, collected from an inelgible donor, were distributed.
Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI,  IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA,  and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.
REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.  Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE  Rx Only     The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
CGMP Deviation; cotton coil is missing in some packaged bottles
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Shimadzu Corporation - Mobile DaRt Evolution     This device is a mobile X-ray system in order to take general radiography of  patients in the hospital who cannot move and/or of out patients in emergency .
The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G.  As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
Nationwide distribution: USA including states of:  CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T     The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T     The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
All Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/Caseinate, Nitrozyme    UPC 6-09492 72000-9 :
expiration date between Jan 2013 and March 2016.
Source of whey ingredient not listed as milk, an allergen.  Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Isolate Whey Protein Chocolate Malt 2.03 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Cocoa, Xylitol ; UPC 6-09492 73010-7
Isolate Whey Protein French Vanilla 1.99 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Xylitol  UPC 6-09492 73011-4
Low Carb Protein -Strawberry/Banana1.78 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate,Soy Lecithin, Red Beet Powder UPC 6-09492 72018-4
Metabolic Whey - Straw/Banana5 LBS & 10 LBS: Whey Protein Concentrate/ Isolate, UPC 6-09492 72052-8, 72055-9
Source of whey ingredient not listed as milk and source of lecithin not listed as soy.  Milk and soy are allergens.  Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products.
UPC6-09492 72050-4,  72053-5 , Metabolic Whey - Rich Chocolate5 LBS, 10 LBS : Whey Protein Concentrate/ Isolate, Cocoa
Source of whey ingredient not listed as milk and source of lecithin ingredient not listed as soy, Milk and soy are allergens.  Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products.
It Works Ultimate Profit Chocolate1.6 LBS: Whey Protein Concentrate/ Isolate, Soy Protein Extract, Soy Hull Fiber; Soy Protein Isolate; Contains: Dairy, Cocoa
:  Product distributed with expiration date between Jan 2013 and March 2016.
Source of whey ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
It Works Ultimate Profit Vanilla1.55 LBS: Whey Protein Concentrate/ Isolate, Soy Protein, Soy Hull Flower Contains: Dairy
Product distributed with expiration date between Jan 2013 and March 2016.
Casein - 100% Micellar Casein - Rich Chocolate2.02 LBS: Soy Lecithin,Casein/Caseinate, Cocoa  UPC 6-09492 72240-9
Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Casein - 100% Micellar Casein - Cookies & Cream2.02 LBS: Soy Lecithin,Casein/Caseinate,Wheat  UPC 6-09492 72242-3
Casein - 100% Micellar Casein - Vanilla Ice Cream2.04 LBS: Soy Lecithin,Casein/Caseinate  UPC 6-09492 72241-6
Massive Muscle Gainer- Weight Gainer French Vanilla10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate  UPC 6-09492 73003-9
Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
Low Carb Protein- French Vanilla1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate  UPC 6-09492 72016-0
All Natural Gainer- Rich Vanilla3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate  UPC 6-09492 73003-9
Low Carb Protein - Creamy Chocolate1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa  UPC 6-09492 72017-7
All Natural Gainer - Chocolate3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa  UPC 6-09492 73004-6
Massive Muscle Gainer- Weight Gainer Dutch Chocolate10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73002-2
Metabolic Whey - Vanilla5 LBS French Vanilla 10lbs: Whey Protein/Isolate, Soy Lecithin  UPC 6-09492 72051-1 (VANILLA)   UPC 6-09492 72054-2 (FRENCH VANILLA)
Source of whey ingredient not listed as milk, an allergen; soy lecithin stated as ''lecithin''.Consumers who have an allergy or severe sensitivity to milk or soy run the risk of a serious or life-threatening allergic reaction if they consume these products.
Fruit-N-Whey 2.03lbs and Fruit-N-Whey Mixed Berries 2.03 lbs: Whey Protein/Isolate, Soy Lecithin. Contains: Dairy, Benefruit Blend, Natural Berry Flavors  UPC 6-09492 72065-8
Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products.
Flax-N-Whey and Flax-N-Whey Vanilla Nut 1.99 lbs: Whey Protein/Isolate Contains: Soy, Dairy, Flaxseed  UPC 6-09492 72064-1
MRM All Natural Whey - Dutch Chocolate 2.02 lbs, 1.01 lbs;  All Natural Whey 10pk/bx Dutch Chocolate: Whey Protein/Isolate Contains: Soy, Dairy, Cocoa, Nitrozyme UPC 6-09492 72004-7 (2.02 lbs)  UPC 6-09492 72095-5 (10 pk)   UPC 6-09492 72005-4(1.01 lbs)
expiration date between Jan 2013 and March 2016. ;
All Natural Whey - Rich Vanilla:  2.02 lbs, 1.01 lbs and   10pk/bx : Whey Protein/Isolate Contains: Soy, Dairy, Nitrozyme  UPC 6-09492 72002-3 (2.02 lbs)   UPC 6-09492 72006-1 (1.01 lbs)   UPC 6-09492 72094-8 (10 pk)
Sprouts Farmers Market Whey Protein Vanilla:  1 lbs, 2 lbs  : Whey Protein/Isolate, Soy Lecithin  UPC 6-46670 68118-9 (1 lbs)   UPC  6-46670 68124-0 (2 lbs)
Sprouts Farmers Market Whey Protein Chocolate:  1 lbs, 2 lbs  : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68120-2 (1 lbs)  UPC 6-46670 68126-4 (2 lbs)
Sprouts Farmers Market Whey Protein Strawberry:  1 lbs, 2 lbs  : Whey Protein/Isolate, Soy Lecithin  UPC 6-46670 68122-6 (1 lbs)   UPC 6-46670 68128-8 (2 lbs):
Delicious Whole-istic Whey Protein Duch Chocolate 1.6 lbs: Whey Protein/Isolate, Contains: Dairy, Soy Lecithin  UPC8-54809 0030-9
Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana
Blood products, collected from an ineligible donor, were distributed.
Nationwide;  Brazil, China, Costa Rica, Germany, Hong Kong, India, Ireland, Mexico, Singapore, Taiwan
Capture-P Indicator Red Cells package 1 x 11.5 mL
Capture-P and Capture-P Ready Screen assays, with confirmed reduced reactivity with the weak positive control, were distributed.
Human Cornea, recovered from a donor whose donor eligibility was not determined in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed.
Human Corneas, recovered using an expired Prep Kit, were distributed.
Nationwide Distribution including IL and IN.
E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.
Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
An LPC Fine Mesh Cassette failed to stay closed during processing operations.
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turknenistan, Venezula, and Viet Nam.
The Constellation Vision System Pneumatic Handpiece.     Indicated for both anterior and posterior segment opthalmic surgery.
All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01
Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01.  This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.
Golden Flower Dried Ginger Net Wt. 6 oz (170g).  Packed By:  S&Y Co., LTD. No 12 Yuenjiang Road, Gaoming City Guangdong, China.  Distributed by:  Prosperity Resources Int'l., Inc. USA.  Product of China.
50 cases (each case contains 50 individual 6 oz. plastic packages)
The Golden Flower Dried Ginger (Net Weight 6 oz. 170 gms) Product of China is in violations to the Agriculture and Markets Law.
Hand Controls for Operon D750, D752, D760, D820 and D850     The hand controls are used to operate OPERON surgical tables
The hand controls are neither serialized nor lot coded.
The firm received complaints for unintended movements.
Worldwide Distribution - USA (nationwide) and internationally to the following countries:  Canada   Austria   Bahrain   Benoni   Centurion   Chatsworth   Czech Republic   Denmark   Egypt   Finland   France   Germany   Ireland   Israel   Italy   Japan   Kuwait   Netherlands   Norway   Portugal   QATAR   Saudi Arabia   Serbia   Singapore   South Africa   Spain   OMAN   Sweden   Switzerland   UAE   United Kingdom   Venezuela
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long   Product Code: ONB5LGF      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Lot Numbers: N2H0414X through N3A0294X     Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short     Product Code: ONB5SHF      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Lot Numbers: N2h0413X through N3A0391X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm  Product Code: ONB5STF      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Lot Numbers: N2H0353X through N3D0033X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm     Product Code: ONB5STF2C      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Lot Numbers: N2J0211X through N3D0118X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Versaport Bladeless Optical Fixation Cannula - 5mm Short     Product Code: ONBFCA5SH      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Lot Numbers: N2J0315X through N3A0389X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Versaport Bladeless Optical Fixation Cannula - 5mm  Product Code: ONBFCA5ST      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Lot Numbers: N2J0150X through N3C0683X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.
FAST Procedure Kit.     Intended for use as a Minor Surgical Procedures Tray.
American Optisurgical, Inc initiated a recall of  ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual  unit packaging.
Nestle USA, Inc - Northbrook Pizza Head Office
US nationwide distribution only.  NO OUS.
DiGiorno pizzeria, bianca/white pizza ,  Net Wt.18.0 OZ (510 g), UPC 71921-91484
Plastic contamination.   Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic
california Pizza Kitchen crispy thin crust, White, Crispy thin crust pizza topped with garlic creme fraiche sauce, spinach, garlic, mozzarella,cheeses, parmesan, asiago and romano cheeses.  Net Wt.12.8 OZ (363 g), UPC 71921-98745
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C),        Product Usage:   A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.
Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop working.
Florida, California, Minnesota, and Maine
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL
Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Maine, Massachusetts, Rhode Island, Connecticut, New York, New Jersey
Whole Foods Salad Chicken Curry , 1 lb plastic bag (bulk)
Whole Foods Salad Curried Vegan Chick N , 1 lb plastic bags (bulk)
Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY.  Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, India, Indonesia, Iran, Italy, Japan, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Syria, Thailand, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Venezuela & Viet Nam.
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143     BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
Worldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico.
Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA     Ear-loop face mask for basic medical/dental procedures.
Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of ''Differential Pressure of only 1.6 Delta P (mm H2O/cm2)'' as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant.
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of  INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850.      Intended to provide general inhalation anesthesia and ventilatory support.
Canisters with date code of 02-2013 (Feb 2013)
GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.
Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.     Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.     Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
Smiling Hill Farm, Inc. dba Silvery Moon Creamery
Smiling Hill Farm brand Butter, 1/2 lb, 5 lb;  Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variable in 5 gallon buckets)   Product in plastic snap-lid containers.
Elevated standard plate counts and detectable coliform bacteria.
Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-13132
Compounding Date: 4/25/13  Discard after: 5/16/13
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132
Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132
a) Compounding Date: 04/30/13 Discard After: 05/21/13  b) Compounding Date: 04/30/13 Discard After: 05/21/13   c) Compounding Date: 04/25/13, 04/30/13   Discard After: 05/16/13, 05/21/13
Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132
Compounding Date: 04/30/13 Discard after: 05/21/13
Sterility could not be assured for compounded sterile renal nutritional prescriptions.
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc  4 Creek Parkway Suite A Boothwyn, PA  19061-3132
Compounding Date: 04/24/13 Discard after: 05/15/13
Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc  4 Creek Parkway Suite A Boothwyn, PA  19061-3132
Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A  Boothwyn, PA  19061-3132
Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc  4 Creek Parkway Suite A Boothwyn, PA  19061-3132
Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA  19061-3132
Compounding Date: 04/24/13                Discard after: 5/15/13
Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA  19061-3132
Compounding Date: 04/23/13                Discard after: 5/15/13
Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA  19061-3132
Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132
Compounding Date: 04/29/13                Discard after: 5/21/13
Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132
Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132
Compounding Date: a) 04/26/13, b) 04/30/13      Discard after: a) and b) 5/21/13
Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
FLEXSTENT Biliary Self-Expanding Stent System.      Product Usage:   The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
FLEXSTENT Femoropopliteal Self-Expanding Stent System.      Product Usage:   The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
ORIGINAL BRAND Arizona SOUTHERN STYLE UNSWEETENED Brewed Tea, Net Wt. 128 FL.OZ (1 GAL.).  Product is packaged in a cardboard case, each case contains four 1 Gallon plastic containers.  UPC Code: 6 1300871981 4.
Codes: KP 072 13 {1004} CT120.    Starting with the time stamp code at 10.04 am and onward
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.     Intended for in vivo imaging.
iVue software version 3.0 and 3.1  3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
Part 510031 Disposable Single Infusion Pump,  quantity Includes...  TOTAL VOLUME:   150mL, 2 mL/hr continuous   Delivery Time : App. 72 hrs when filled to capacity   Sterile EO...     found in the following GoPump Kits:     GoPump Kit 510042, w/ Epidural Catheter   GoPump Kit  510042 - BP, w/ Epidural Catheter, BIOPATCH   GoPump Kit 510110,  w/2.5'' Fenestrated Catheter     GoPumpKit 510110-BP,  w/2.5'' Fenestrated Catheter,BioPatch     GoPumpKit 510350  w/ Epidural Catheter    GoPump Kit 510350-BP  w/ Epidural Catheter, BIOPATCH   GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH      Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication.
Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile,  found in the following kits: GoPump kit 510080-BP,  5 fenestrated catheter & BIOPATCH;   GoPump kit 510112-BP,  2.5'' fenestrated catheter & BIOPATCH   Go Pump Kit 510141-BP,10'' fenestrated catheter& BIOPATCH      Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL,  2mL/hr,...  found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH;   Go Pump Kit 510349-BP, Epidural Catheter, BioPatch;    Go Pump Kit 510642    Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate
Part 510121 Disposable Infusion Pump, ...Elastomeric  Pump 300 mL,  4mL/hr,...sterile..  found in the following kits  GoPump Kit 510203-BP, Epidural catheter & BIOPATCH   GoPump Kit 510204, 2.5'' Fenestrated catheter   GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch   GoPump Kit 510205BP, 5'' Fenestrated catheter & Biopatch   GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch   GoBlock kit 510608   Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Part510447 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL,  2mL/hr/side,...  found in the following kits  GoPump Kit 510462-BP, 5 '' catheter & BIOPATCH   GoPump Kit 510558-BP 10 '' catheter& BIOPATCH   GoPump Kit 64310       Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Part 510449 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 8mL/hr ),...  found in the following kits  GoBlock Kit 510472,   Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
Part 510450 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 10mL/hr ),...  found in the following kits  GoBlock Kit 510458,   Disposable Single Infusion Pump
Part 510490 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 300 ml per side)( 6mL/hr ),...  found in the following kits  GoBlock Kit 510491,   Disposable Single Infusion Pump for drug delivery
Part 510613 Disposable  Infusion Pump, ...Elastomeric  Pump 300mL (150 mL side)( 6mL/hr ),...  found in the following kits  GoBlock Kit 510612,      Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
Part 510636 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 300 ml perside), 2 to 10 ml/hr.  Delivery time 60 to 144 hours;  found in the following kits:  GoBlock Kit 510646,      Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
Active Articulation E1.     Intended for use with either primary or revision hip arthroplasty.
Biomet is recalling Active Articulation E1  Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size.  The implant itself is etched with the correct O.D. size.
Worldwide distribution - USA (nationwide)  Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears)     Manufactured and Distributed by:   Intuitive Surgical   Sunny vale, CA        The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
AGFA Digital Radiography X-Ray System DX-D 100     Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368.     For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Reagent Lot Number: 056301 and 56302  Kit Lot Number/Exp. Date:   61655301 09 Nov 2011   61950302 09 Nov 2011
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361.     For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394.     For in vitro diagnostic use in calibrating Intact PTH assays.
ADVIA Centaur iPTH Calibrator 6 pk; REF:  10492387, 10630628.     For in vitro diagnostic use in calibrating Intact PTH assays.
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA  01722-2104     Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ,  IL, FL, WI, AL,  ME, OH, NE, NV, IN, and CA
Cottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 24 OZ (680 g), UPC 044100104916, HP HOOD LLC, LYNNFIELD, MA 01940; (c) Big Y brand Small Curd Cottage Cheese With Chives, 4% MILKFAT, NET WT 16 OZ (1 LB) 453g, UPC 018894300960, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104.
4% Cottage Cheese distributed under the following labels and sizes: (a) Hannaford brand Cottage Cheese, 4% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268114504, DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (b) Weis brand SMALL CURD original cottage cheese, 4% MILKFAT MIN., NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096855, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (c) Big Y brand Small Curd Cottage Cheese, 4% MILK FAT MIN, NET WT 24 OZ (680g), UPC 018894300984, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (d) Shurfine brand SMALL CURD Cottage Cheese, 4% MILKFAT, NET WT 24 OZ (1LB 8 OZ) 680g, UPC 015400832984, Distributed By: Western Family Foods, Inc. Portland, OR 97208; (e) Friendly Farms brand Small Curd Cottage Cheese, 4% MILKFAT MINIMUM, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041498192174, Distributed by ALDI, Inc., Batavia, IL 60510.
1% Low Fat Cottage Cheese distributed under the following labels and sizes: (a) Fiber One brand Lowfat Cottage Cheese, 1% Milkfat Minimum, NET WT, 16 OZ (453g), UPC 041483035585, DISTRIBUTED BY HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Low Fat Cottage Cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (680g), UPC 044100106330; HP HOOD LLC, LYNNFIELD, MA 01940; (c) Hannaford brand Lowfat Cottage Cheese, 1% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268148615, DISTRIBUTED BY; HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (d) Weis brand lowfat cottage cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096886, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (e) Big Y brand Small Curd Low Fat Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8Z) 680g, UPC 018894300977, DISTRIBUTED BY: BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (f) Market Basket brand Lowfat Cottage Cheese, Small Curd, 1% Milkfat, NET Wt. 24 OZ. (680g), UPC 049705682968, PACKED EXCLUSIVELY FOR DEMOULAS SUPERMARKETS INC., TEWKSBURY, MA 01876; (g) Shurfine brand LOWFAT Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 015400834605, Proudly Distributed By: Western Family Foods, Inc., Portland, OR 97208; (h) Friendly Farms brand Small Curd Cottage Cheese, Low Fat, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680 g, UPC 041498154905.
Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.
Hill-Rom 1000 Bed,   Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.
Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.
Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.
Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.
The Zimmer Air Dermatome, REF  00- 8801- 001- 00 ,  Rx, non-sterile      grafting instruments intended to provide variable graft thickness and width capabilities
This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken.  This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
Zimmer Air Dermatome II, REF 00-8851-001-00  handpiece   Rx, non-sterile      grafting instruments intended to provide variable graft thickness and width capabilities
Zimmer Air Dermatome II, REF 00-8851-001-01  handpiece, w/o hose, Rx, non-sterile      grafting instruments intended to provide variable graft thickness and width capabilities.
This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or  operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken.  This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK  74146.
25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00
Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.
US Distribution to: KY, MI, OH, PR, TX, and VA.
Digitex Absorbable Polydiaxanone Suture, Size 2-0.   Catalog Number / Code of product: 52031, 5203101400.      The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 0400-710-000  T4 Pullover Toga (S/M)    Sterile, EO; single use;    Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use;         Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-720-000S5 T5 Pullover Toga  w/Peel Away,  Sterile, EO; single use.      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular  Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large  Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large  Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-810-000 T4 Zipper Toga  (S/M) Sterile, EO; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-820-000 T4 Zipper Toga  (L/XL) Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-820-000S3 T4 Toga w/Inside  Shoulder Ties, Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3  Cut, Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-820-100 T5 Zipper Toga  with Peel Away, Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments  0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-850-000 T4 Toga, Zipper,  (XL-Tall) Sterile, EO; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Stryker Instruments 0400-850-100 T5 zipper Toga  with Peel Away, Sterile, EO; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.