Recalling Firm
Talecris Plasma Resources Inc Dba International Bioresources
Marquette General Hospital, Inc, UP Reg Bl Ctr Marquette
Blood Centers of the Pacific - Irwin Center
Community Blood Centers of South Florida, Inc.
Lifesouth Community Blood Centers - Montgomery Region
Oklahoma Blood Institute - Sylvan N Goldman Center
Stryker Instruments Div. of Stryker Corporation

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

Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, 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, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
USA Nationwide Distribution including the state of TX
Worldwide Distribution - USA (nationwide), and countries of: Canada and Novia Scotia.
Nationwide distribution: USA including states of: AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA.
Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.
Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.
Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates.
Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Australia, Belgium, China, Denmark, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, and Turkey.
Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
NY, NJ, CT, ME, PA, MD, NC, IN, TX, IL, FL, UT, CO
Worldwide Distribution - USA (nationwide) and Canada.
US distribution to: AZ, FL, IL, IN and TX.
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
The product was distributed only to two consignees in the state of Ohio.
Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.
US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
The affected product was only distributed in the states of WA and OR.
The affected product was distributed to the following states: Indiana, Kentucky, Michigan, New York, Ohio, and Pennsylvania.
Alaska, CT, ID, IL, IN, MD, MA, MT, NH, NJ, NY, NC, OH, PA, TN, VA, WA and WI.
United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.
Distribution centers in CA, OH, GA, KS and SC and then on to stores in AZ, FL, HI, MO, NC,NE, NV, NY, OK, PA, TX and WV.
Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.
Nationwide Distribution including PA, CT, DE, and NY.

Product Description
Plasma Frozen Within 24 Hours After Phlebotomy (FP24)
Red Blood Cells (Apheresis) Leukocytes Reduced
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Item # H996189 Mango Diced 1/2'' 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
Item # H175455 Mango Sliced 2/2.5 LB and 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
Item # 2999 Mango Chunks 2/5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Deglycerolized Leukocytes Reduced
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
Pet Shoppe Chicken Jerky premium chicken dog treats, packaged in 20 ounce bags and 3.5 ounce bags. Distributed by Walgreen Co. Deerfield , IL Product Code: 7NPS420672 (3.5 ounce) and 7NPS420673 (20 ounce) Made in China
Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
KENTON'S CHEESE CO. Bianco A soft Brie-Style cheese Aged at least 60 days, Net Wt. 8 oz wheel. Distributed by Kenton's Cheese Company 5939 Burr Rd. Trumansburg, NY 14886.
Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS'').The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).
PISTACHIOS-INSHELL-R/S-21/25-6.25LB, Net Wt. 6.25 LB. Item number: 920. Product is packed in a clear plastic liner then in a white corrugated bag. Distributed by Nassau Candy 530 West John Street Hicksville, NY 11801.
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
RAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap.
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
QFC Chicken Pesto Panini wrapped in polywrap packaging, 10.32 oz. in size, included with five (5) other types of sandwiches in a 6-count ''variety pack'' case.
Broccoli Salad Kit No Dressing, packaged in plastic bags inside paper cartons, 4 bags per case.
Broccoli Salad Kit No Dressing, No Bacon; packaged in plastic bags inside paper cartons, 4 bags per case.
Broccoli Salad Kit with Dressing; packaged in plastic bags inside paper cartons, 5 bags per case.
Sweet & Sassy Apple Salad; packaged in plastic bags inside paper cartons, 5 bags per case.
Sani Fresh Distribution brand MINI KAISER 10, Net Weight 13 OZ, Product of Canada, UPC 0 56931 51125 2 --- DISTRIBUTED BY SANI BAKERY INC. 28-24 STEINWAY ST., SUITE 108, ASTORIA NY 11103 --- The mini kaisers are packed in clear plastic sealed bags (contain 10 rolls per bag) which are placed in unmarked brown boxes/cartons. The product has a short shelf life.
Talenti Gelato, Toasted Almond, One Pint (473ml), Crafted by: Talenti, Marietta, GA 30062
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Somersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111.
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60211.
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60311.
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411.
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511.
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations.
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin

Code Info
Catalog number: 500V* and serial numbers: 1564-1566
All mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0908 and 0913 located on top film of tray and also on the outer box.
All mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0909 and 0908 located on top film of the tray and also on the outer box.
All mango products manufactured from mangos sourced by Agricola Daniella. Lot Number 0913 located on top film of the tray and also on the outer box.
510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
Lot/batch Number: CM040212; Exp. Date: April 2014
All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.
The affected product includes finished product lot number 0943, which was made using supplier lot number PRO-1349.
Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.
The affected product has a sell by date of 06/22/13 and a UPC code of 1111039114.
The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74716, Broccoli Salad Kit No Dressing, 3.625lb per case, 6/17/2013.
The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74717, Broccoli Salad Kit No Dressing No Bacon, 3.375lb per case, 6/17/2013.
The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74807, Broccoli Salad, 4.04lbs per case, 6/17/2013.
The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74891, Sweet & Sassy Apple Salad, 6.125lbs per case, 6/17/2013.
BOX UPC: 0 898403 00221 5 (located on the bottom of the box); PACKAGE UPC: 0 898403 00220 8 (located on the rear panel of each package;) SELL BY DATES: FEB061483 and FEB061481.

Product Quantity
70,638 (combined total for Eon and Eon mini systems)
70,638 (combined total of the Eon and the Eon Mini systems)
7,968 units of 10 oz bags, 24 bags/case; 332 cases total
712 cases. Each case contains 6 boxes of 6-count multi packs.

Reason for Recall
Blood product, incorrectly labeled as negative for the Jka red cell antigen, was distributed.
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor whose annual physical examination was inadequately documented, were distributed.
Source Plasma, which reached unacceptable temperatures during storage and was not relabeled as Source Plasma, Salvaged, was distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood products, collected from a donor with a history of incarceration, were distributed.
Blood products, collected from a donor who was deferred for a history of Hepatitis A, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who did not have a physical examination, were distributed.
Source Plasma, collected from donors who did not have a complete medical history interview, was distributed.
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia.
The product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Blood product, with an unacceptable low volume which was not labeled as a low volume unit, was distributed.
Blood product, tested for viral markers using a sample that was diluted with saline, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, which did not meet the minimum requirement for Red Blood Cell recovery, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, for which the quality control testing was not performed, were distributed.
One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
Blood products, which did not undergo the required quality control testing, were distributed.
Blood products, quarantined pending discard, were distributed
Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of United States origin, water, and/or cell growth promoting additives.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Blood products, with platelet counts below the specified minimum requirement, were distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.
Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys -CrossLaps (-CL) assay package insert version 5, could not be reproduced. The -CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosis in the short term. To date, no customer complaints have been reported.
A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.
Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.
Vascular grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Cardiac grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Human tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Human vascular allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Heart Valves, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Cardiac tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Boston Scientific has discovered an inconsistent ''Use By'' expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.
Pet treats contain trace amount of antibiotics
Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.
As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.
Miscalibrated Fill Level Sensor may affect dosing level
Kenton's Cheese Co. is recalling Bianco A Soft Brie-Style Cheese due to E.coli contamination. Consumers who have purchased Bianco-Brie from Kenton's Cheese Co. between May 9, 2013 and May 19, 2013 listed with Batch number 13064, are urged to return the product to Kenton's Cheese Co. 5939 Burr Road Trumansburg, NY 14886. Questions may be directed to Kenton Burr (607) 592-0746 or via e-mail kenton@kentonscheeseco.com. A full refund will be provided by Kenton's Cheese Co.
The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.
Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Subpotent Drug; 15-month stability test station
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Windy Acres Candy and Nut recalled the affected product because they were informed by the supplier, Lipari Foods, that the sunflower seeds were potentially contaminated with Listeria monocytogenes.
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there is a remote potential that additional intervention would be required due to a non-functioning clamp.
The paninis may contain soy and egg, which are allergens.
The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes.
Canadian firm recalled Mini Kaiser 10 due to undeclared soy in the product. The product was also found to contain undeclared wheat, sulfites, soybean oil and gluten (barley and/or rye) all from the Doughmaster 200 raw material.
Product contains undeclared Allergen; Pecans.
During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
A limited number of packages of 1 ounce Somersault Pacific Sea Salt products were inadvertently mispackaged - Somersault Santa Fe Salsa flavored product were inadvertently commingled with Somersault Pacific Sea Salt flavored product in packages labeled as Somersault Pacific Sea Salt.
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set.
A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medecin via Kermit) or HL7 must be absolutely prohibited. Such symbols are not supported by the Microsoft Word interface used by the Histology/Cytology software and this could potentially lead to the wrong conversion of symbols less than or equal to or greater than or equal to into ''=''.
Lancets were not sterilized within the dose range established by sterilization validation.
The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.