Recalling Firm
Community Blood Centers of South Florida, Inc.
Community Blood Centers of Florida, Inc.
American Red Cross Greater Alleghenies Region
Lifesouth Community Blood Centers - Montgomery Region
Northern Illinois Blood Bank dba Rock River Valley BC
Faria Limited LLC dba Sheffield Pharmaceuticals

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Nationwide Distribution - including all states, none internationally .
AZ, CA, ID, MD, MI, NV, OK, OR, PA, TN, UT.
Massachusetts, California, New York, and Oregon.
Worldwide Distribution - US Nationwide and the country of Canada.
Worldwide Distribution - USA Nationwide and the country of Canada
Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.
Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
Worldwide distribution: USA (nationwide) including states of : AK, AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Washington DC, Guam, and countries of : Argentina, Australia, Brazil, Canada, China, Ecuador, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Japan, Malaysia, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, The Netherlands, United Kingdom, and Venezuela.
Worldwide Distribution - USA Nationwide: CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI. and the countries of Netherlands, Costa Rica, Japan, and San Juan.
Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
Worldwide Distribution - USA including CA, CO, CT, FL, GA, IL, NY, NY NC OH, TX, VA, WV, WI. Internationally to: AUSTRALIA, AUSTRIA, BAHARIN, CANADA, CHILE, CHINE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, JAPAN, KOREA, MEXICO, MOROCCO, NIGERIA, POLAND, ROMANIA, RUSSIA,SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM.
Nationwide Distribution to the states of FL, NY, and PA.
Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
Product was distributed to 8 domestic distributors, and 1 foreign distributor in Canada.
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Distribution was made to AL, AR, AZ, CO, DE,FL,GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT and WI. No foriegn or military distribution was made.
Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt , Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Libya, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Utd.Arab.Emir. and Vietnam.
Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, IL, IN, KS, KY, MD, NC, ND, NY, OH, OR, PA, TX, VA, WA, and WI. One (1) system unit was also distributed to Mexico.

Product Description
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
Blood and Blood Products for Reprocessing
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
Ginseng. American Ginseng, 4 oz. and 8 oz. retail packages and bulk ginseng in 20, 30, or 40 lbs. in a clear plastic bag. Bulk products are not labeled.
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response.
Roo's Juice Tropical Orange Flavor (5% juice beverage) 10 FL OZ. (296 mL) Distributed by The Pantry, Inc. Sanford, NC 27330
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
''***SOGevaL***KETOSEB FLUSH+PS Chlorhexidine 2%, Ketoconazole 0.2%, Phytosphingosine 0.02% Topical Antiseptic Formulation with Astringent, Cleansing and Drying Properties.***16 FL OZ***Contact Sogeval Laboratories, Inc., Oldsmar, FL, 1-800-877-0177***''.
Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03
Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
Lightlife Farmer's Market Veggie Burgers, meat free, 12 oz/4-count bag, packaged in 5/12 oz-bag/cartons. Distributed By: Lightlife Foods, Turners Falls, MA. Case UPC Code: 20043454805252
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.
Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument.
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)
MINUTE MAID ORANGE JUICE, 10oz and 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
MINUTE MAID APPLE JUICE, 100% Juice, 6/10 oz and 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
MINUTE MAID CRANBERRY APPLE RASPBERRY Flavored Juice Beverage, 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
MINUTE MAID STRAWBERRY PASSION Flavored Juice Beverage, 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
MINUTE MAID Mixed Berry Juice, Flavored Blend of Apple, Grape & Berry Juices, 6/10 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.
Gromex Camaron Entero (Whole Shrimp) Net Wt. 1 1/2 oz. 43 First St., Passaic, NJ 07055 (973) 458-9399
Gromex Anelina Net Wt. 1/2 oz. Gromex 43 First St., Passaic, NJ 07055 (973) 458-9399
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Box: Oskri, Sesame Bars Date Syrup, Gluten Free, Halal Vegetarian, 5 Bars each 1.9 oz (53g) total weight 9.5 oz (265g), UPC 6 66016 40052 6. Individual bar: Oskri Sesame Bar With Date Syrup,Gluten Free, Net WT 1.9 oz (53g)
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
vega one, all-in one nutrition bar; chocolate almond flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC: 838766070049
vega one, all-in one nutrition bar; chocolate cherry flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC: 838766070056
vega one, all-in one nutrition bar; Double chocolate flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766070032
vega sport, Natural Plant-Based Protein Bar; Chocolate Coconut flavor Gluten Free; 2.1 oz/ 60g Complete protein '' 4g of fiber per serving '' 0.4g of Omega-3 per serving Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766008301
vega sport, Natural Plant-Based Protein Bar; Chocolate Saviseed flavor Gluten Free; 2.1 oz/ 60g Complete protein '' 4g of fiber per serving '' 0.4g of Omega-3 per serving Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766008301
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.
ALL NATURAL Julian's RECIPE European Style Pretzel Baguette, BUTTER & SEA SALT, NET WT 11.3 OZ (320 g), UPC 8 55971 00226 9, 2 BAGUETTES, KEEP FROZEN -- Product of Germany. Manufactured for Distribution by Julian's Recipe, LLC PO Box 323, Montgomery, NY 12549. --- The product consists of a frozen pre-baked baguette filled with salted butter. The baguette was treated on the surface in a manner to obtain the characteristic appearance of a pretzel. The deep frozen and unwrapped baguette should be baked in a pre-heated oven at 180-200C for about 10-12 minutes until the butter inside becomes liquid.

Code Info
Part Number 241.000.011, lot number S2004
Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
Lot # 1529-17-2636, expiration date 12 June 2013
Model, Part and Serial Numbers: Model # GVL 3, Part # 0574-0007, Serial # range MD112388 to MD121908; Model # GVL 4 Part # 0574-0001 Serial # range LG112759 to LG122582; Model # GVL 5 Part # 0574-0030 Serial # range XL111799 to XL121759; Model # AVL 2 Part # 0574-0118 Serial # range AC111500 to AC121604; Model # AVL 3 Part # 0574-0115 Serial # range AD111500 to AD121688; Model # AVL 4 Part # 0574-0116 Serial # range AE11150 to AE121778; and Model # AVL 5 Part # 0574-0117 Serial # range AF111500 to AF121666.
No codes or lot numbers used. Production start and end date: 2/1/2013 - 3/31/2013
Catalog number: 14-442021 and lot number:757910
Catalog number: 010001814 and lot numbers: 318520 and 644720.
Lot Code: 5483220300 and 5483221700 Best if Used by Dates: JULY 16 2013 and JULY 30 2013.
Instrument Freedom EVO 100 Base Unit: Material number: 10641100, Serial numbers: 1211001569, 1212000203 and 1212000205; Instrument Freedom EVO 100 MCA: Material number: 30020010, Serial number: 1301007643; Instrument Freedom EVO 150 Base Unit: Material number10641150, Serial number: 1301006708; Instrument Freedom EVO 150 MCA: Material number: 30020015, Serial number: 1211007442; Instrument Freedom EVO 150 MCA384: Material number: 30032015, Serial number: 1211011594 and 1109003270; Instrument Freedom EVO 200 Base Unit: Material number: 1641200, Serial number: 1106003923 and 1211011578 and Instrument Freedom EVO 200 MCA: Material number: 30020020, Serial number: 1208007288 and 1208007284.
(15.2 oz) Optimum Taste Date Code: OCT0713MDF3, OCT0713MDE3, OCT1413MDC3, OCT1413MDB3, UPC Code: 025000056031; (10 oz) Optimum Taste Date Code: SEP2313MDF3, SEP3013MDC3 and SEP3013MDE3, UPC Code: 10025000056779, GTIN Unit UPC: 00025000056772.
(10 oz) Optimum Taste Date Code: SEP3013MDB3, SEP3013MDD3 and SEP3013MDF3, UPC Code: 10025000056762, GTIN Unit UPC: 00025000056765; (15.2 oz) Optimum Taste Date Code: JAN0614MDC3 and JAN1314MDA3, UPC Code: 025000056017.
Optimum Taste Date Code: NOV0413MDB3, UPC Code: 025000056024.
Optimum Taste Date Code: NOV0413MDD3 and NOV1113MDA3, UPC Code: 025000048906.
Optimum Taste Date Code: SEP2313MDD3 and SEP3013MDE3, UPC Code: 10025000056793, GTIN Unit UPC: 00025000056796.
Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02
The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067, M071, M084, M106-M108, M110-M141 inclusive, and M952 Echelon Oval - Y001-Y005 inclusive
Lot Code L2312, Best Before Date 02/10/2014 (located on the bottom right hand corner of the box)

Product Quantity
478 total (339- Domestic) (139- International)
4784 units worldwide (3,381 in the US and 1403 international)
42 cases (40 boxes per case) (5 bars per box)
168 cases for total lot (only 23 cases contained incorrect product)

Reason for Recall
Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
Blood products, collected from donors whose arm scrub procedures were performed incorrectly, were distributed.
Blood product, which tested positive for S antigen, but was labeled as S antigen negative, was distributed.distributed..
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who was deferred due to risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Blood products, collected from donors whose physical examinations were incomplete, were distributed.
Blood products, which were not quarantined subsequent to receiving disqualifying post donation information, were distributed.
An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment
Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used
Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.
The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, which was incorrectly labeled as negative for the Jk(a) red cell antigen, was distributed
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood product, which was not quarantined after the donor provided information concerning a post-donation illness, was distributed.
Blood product, collected from a donor who was previously deferred, was distributed.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood product, for which the quality control testing was incomplete and not documented , was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood product, which did not meet required specifications, was distributed.
Blood product, which was not quarantined subsequent to receiving post donation medical information, was distributed.
Blood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed
Blood product, which was collected from a donor who had traveled to an area considered endemic for malaria, was distributed.
Blood products, which were collected from a donor who had traveled to an area considered endemic for malaria, were distributed.
The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
The firm is recalling the specific lot due to lower than expected results.
Subpotent; 24 month stability test station
Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.
The firm initiated this recall of ''American Ginseng'' because FDA lab analysis found pesticide residues.
Biomet Trauma (''Biomet'') has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in surgery of greater than 30 minutes may occur.
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.
The product has the potential to contain polysaccharide-based bacterial biofilm, mold, and red water mites.
There was an error on the outer labeling of this device. The inner label was correct.
The product does not meet the firm's size standards, the product was produced in the incorrect size.
Recall due to an error on the label in which the concentration of Chlorhexidine is reported as 2%, however the actual concentration is 0.2%
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Subpotent Drug: Product is being recalled due to an out of specification dissolution result during stability testing.
The product packaging for Lighthouse Farmer's Market Veggie Burgers may contain Lightlife Kick'n Black Bean Burgers which contain milk. The milk allergen is not declared on the Farmer's Market Veggie Burger product label.
WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. If an operator presses ''Continue'' following a Rich User Prompt and the door has been left open, the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside the Freedom EVO's working area.
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Failed Stability Specifications: Unable to meet shelf life expiry.
Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle.
Whole dried shrimp may contain undeclared bi-sulfites. Anelina contains undeclared and unapproved colors..
Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.
Oskri Corp. of Lake Mills, WI is recalling 1650 (5 pack) of ''Sesame Bars Date Syrup'' because they may contain copper shavings.
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction.
Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost. If the two datasets have similar anatomy, position, and orientation, the error could potentially lead to a misdiagnosis.
Undeclared allergen, soy flour, due to repacking error.