Recalling Firm
The American National Red Cross - Southern Region
Blood Centers of the Pacific - Irwin Center
DePuy Mitek, Inc., a Johnson & Johnson Co.
Philips And Neusoft Medical Systems Co., Ltd.
Varian Medical Systems, Inc. Oncology Systems
Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding

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

Distribution Pattern
Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)
Nationwide and Puerto Rico (through the internet).
Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.
Nationwide Distribution including NV, WI, MD,and CA.
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, DE, FL, HI, IA, IN, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VT, WI, WV, and WY; and the countries of: Argentina, Australia, Bahrain, Brasil, Canada, China, Denmark, Finland, France, Germany, Greece, Haiti, Hong Kong, Hungary, Indonesia, Iran, Israel, Italy, Japan, Korea, KSA, Mexico, Netherlands, Norway, Pakistan, Portugal, Rep. DE Panama, Saudi Arabia, Spain, Switzerland, Taiwan ROC, Thailand, Turkey, and United Kingdom.
Florida, New Jersey, Pennsylvania, Massachusets and New Hampshire and Maryland.
Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI and the countries of TAIWAN, TURKEY, SINGAPORE, SWD EN, PORTUGAL, POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MALAYSIA, MEXICO, SOUTH KOREA, JAPAN, ITALY, INDIA, ISRAEL GREAT BRITAIN, FRANCE, DENMARK, GERMANY, SWITZERLAND, CANADA, BRAZIL BELGIUM, AUSTRALIA, and ARGENTINA.
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.
Worldwide Distribution - USA, including Canada and Puerto Rico and the states of NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech Republic, Japan, Germany, Brazil, China, Italy, Ireland, Israel, India, Hong Kong, Malaysia, Netherlands, Spain, Switzerland, France, Taiwan, Turkey, United Kingdom and Vietnam.
Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
retail grocery stores in Indiana and 1 retail store in Illinois
Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.
Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.
Nationwide including: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IN, KY, KS, LA, ME, MD, MI, MO, MS, NC, NJ, NM, NE, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY.
Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom.
The two different products were distributed to two different restaurants (one for each) located in Oregon
Sold through recalling firm's owned retail market in California.
Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).
Meijer Distribution Centers and Retail Stores: Illinois, Indiana, Kentucky, Michigan, and Ohio

Product Description
Red Blood Cells, Leukoreduced, Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
Platelets Pheresis Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Red Blood Cells Leukocytes Reduced Irradiated
WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
MTS Anti-IgG Cards (Catalog # MTS 084024)
MTS A/B/D Monoclonal and Reverse Grouping Card (Product Code MTS080515)
APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10degree 184016-10 Anterior Psoas Lumbar 18 x 40 x 16mm - 10degree 184008-00 Anterior Psoas Lumbar 18 x 40 x 08mm - 00degree 184010-00 Anterior Psoas Lumbar 18 x 40 x 10mm - 00degree 184012-00 Anterior Psoas Lumbar 18 x 40 x 12mm - 00degree 184014-00 Anterior Psoas Lumbar 18 x 40 x 14mm - 00degree 184016-00 Anterior Psoas Lumbar 18 x 40 x 16mm - 00degree 184510-08 Anterior Psoas Lumbar 18 x 45 x 08mm - 10degree 184510-10 Anterior Psoas Lumbar 18 x 45 x 10mm - 10degree 184512-10 Anterior Psoas Lumbar 18 x 45 x 12mm - 10degree 184514-10 Anterior Psoas Lumbar 18 x 45 x 14mm - 10degree 184516-10 Anterior Psoas Lumbar 18 x 45 x 16mm - 10degree 184510-00 Anterior Psoas Lumbar 18 x 45 x 10mm - 00degree 184512-00 Anterior Psoas Lumbar 18 x 45 x 12mm - 00degree 184514-00 Anterior Psoas Lumbar 18 x 45 x 14mm - 00degree 184516-00 Anterior Psoas Lumbar 18 x 45 x 16mm - 00degree 185008-10 Anterior Psoas Lumbar 18 x 50 x 08mm - 10degree 185010-10 Anterior Psoas Lumbar 18 x 50 x 10mm - 10degree 185012-10 Anterior Psoas Lumbar 18 x 50 x 12mm - 10degree 185014-10 Anterior Psoas Lumbar 18 x 50 x 14mm - 10degree 185016-10 Anterior Psoas Lumbar 18 x 50 x 16mm - 10degree 185008-00 Anterior Psoas Lumbar 18 x 50 x 08mm - 00degree 185010-00 Anterior Psoas Lumbar 18 x 50 x 10mm - 00degree 185012-00 Anterior Psoas Lumbar 18 x 50 x 12mm - 00degree 185014-00 Anterior Psoas Lumbar 18 x 50 x 14mm - 00degree 185016-00 Anterior Psoas Lumbar 18 x 50 x 16mm - 00degree 185508-10 Anterior Psoas Lumbar 18 x 55 x 08mm - 10degree 185510-10 Anterior Psoas Lumbar 18 x 55 x 10mm - 10degree 185512-10 Anterior Psoas Lumbar 18 x 55 x 12mm - 10degree 185514-10 Anterior Psoas Lumbar 18 x 55 x 14mm - 10degree 185516-10 Anterior Psoas Lumbar 18 x 55 x 16mm -
Orthopedic Alliance Spine System (alias ''Blue & Gold'') Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod 5.5 x 90mm BGR0100 Straight Rod 5.5 x 100mm BGR0110 Straight Rod 5.5 x 110mm BGR0120 Straight Rod 5.5 x 120mm BGR0130 Straight Rod 5.5 x 130mm BGR0140 Straight Rod 5.5 x 140mm BGR0150 Straight Rod 5.5 x 150mm BGR0200 Straight Rod 5.5 x 200mm BGR0300 Straight Rod 5.5 x 300mm BGR0400 Straight Rod 5.5 x 400mm BGR0500 Straight Rod 5.5 x 500mm BGS5535 5.5 x 35mm Polyaxial Screw BGS5540 5.5 x 40mm Polyaxial Screw BGS5545 5.5 x 45mm Polyaxial Screw BGS6035 6.0 x 35mm Polyaxial Screw BGS6040 6.0 x 40mm Polyaxial Screw BGS6045 6.0 x 45mm Polyaxial Screw BGS6050 6.0 x 50mm Polyaxial Screw BGS6535 6.5 x 35mm Polyaxial Screw BGS6540 6.5 x 40mm Polyaxial Screw BGS6545 6.5 x 45mm Polyaxial Screw BGS6550 6.5 x 50mm Polyaxial Screw BGS7035 7.0 x 35mm Polyaxial Screw BGS7040 7.0 x 40mm Polyaxial Screw BGS7045 7.0 x 45mm Polyaxial Screw BGS7050 7.0 x 50mm Polyaxial Screw BGS7055 7.0 x 55mm Polyaxial Screw BGS7535 7.5 x 35mm Polyaxial Screw BGS7540 7.5 x 40mm Polyaxial Screw BGS7545 7.5 x 45mm Polyaxial Screw A pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,
Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Harvest Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Easter Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
The Alere Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.
VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
Bakehouse Granola, 12 oz, 340 g, Scholar's Inn Bakehouse Granola 16 oz, 454 g All Natural, Baked locally
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
all One Active Senior Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters
all One Original Formula Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters
Yum Nature Tahini, Net Wt. 18oz (1lb.2oz.)510g,12 jars/case
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Kwong Hung Seng Sauce - Thin Soy Sauce Product is packaged in bottles Net Wt 19 Fl oz - 12 bottles per case
Pantai Thai Tea The tea is packaged in a foil laminated pouch Product of Thailand
Cabrales Rojo Prieto Cheese, 1.9 kg or 4.1 lbs each wheel. 2 units per carton.
Chappaqua Crunch GF(Gluten Free) Simply Granola with Flax & Fruit , 12 ounce pouch UPC: 786516-76002 6
Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution information on the label. A general label template was provided with attachment B information. Product is sold in 50 and 100 ct bottles.
Jasmine Brand Garlic Flavored Crackers (Krupuk Bawang), 40x250gr.
Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10
Meijer Essential M with Real Strawberries, 12 oz.
Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.
Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.
Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.
TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Code Info
Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP Model HSYS-REC-DUO-PPC Model HSYS-REC-DUO-PPC Models HSYS-RDR-D, HSYS-RDR-T
distributed between 8/2012 and 3/1/2013.
Model Number 12-807. Lot/Unit Codes: 274632, 281847 Expiration date, or Expected shelf life: 5/5/13, 6/30/13
ALL from Jan 1 2010 - Corrected IFU implementation date
All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.].
Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.
Product shipped to one consignee 3/26/12 No lot code No UPC
All Best By Dates between 10/01/13 and 11/10/13
Best Before date of Oct 26 2013 Lot Code: S1596OCT2613A

Product Quantity
Domestic: 11,164 units, Foreign: 594 units

Reason for Recall
Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.
Blood products, which were not quarantined after receiving post donation information concerning prior incarceration, were distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood product, collected from a donor with an elevated body temperature, was distributed.
Blood products, which were possibly contaminated with Diptheroids, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, which reached an unacceptable temperature during shipment, were distributed.
Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.
Blood products, collected from a donor with a history of intravenous drug use, were distributed.
Blood product, collected from a donor whose body temperature was not documented, was distributed.
Blood product, with a low platelet count, was distributed.
Blood products, for which the quality control testing was not performed, were distributed.
Blood products, collected from a donor with a history of incarceration, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, collected from a donor with a history of hepatitis, were distributed.
Blood products, collected from a donor who may have received a piercing within 12 months of donation, were distributed.
Blood products, collected from a donor with a history of high-risk behavior, were distributed.
Blood products, collected from a donor whose record was incomplete, were distributed.
Blood product, which was labeled as negative for hepatitis B surface antigen (HBsAg), but tested positive for HBsAg, was distributed.
Blood product, which tested positive for the human immunodeficiency virus (HIV), but was labeled as negative for HIV, was distributed.
Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed.
Blood products, which did not meet the minimum requirement for volume, were distributed.
Blood product, which tested positive for anti-HBc, was distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected from donors who may have traveled to an area considered endemic for malaria, were distributed.
Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, stored at unacceptable storage temperatures, were distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, failed to meet the minimum specification for deglycerolized components, were distributed.
In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed.
Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.
Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.
The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.
Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 and Blue #2.
Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1
Glucose test strips reports no result message when tested
GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
The Alere Cholestech LDX hsCRP cassette (PN 12807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.
The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation.
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.
Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
Bake House Granola, does not list the source of the unsalted butter ingredient as milk, an allergen. People who have an allergy or severe sensitivity to milk, run the risk of serious or life-threatening allergic reaction if they consume these products.
Blood products, collected from a donor with risk factors for vCJD, were distributed.
User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
Product label misprinted to include claim of ''No Dairy'', even though milk is present in an ingredient (whey protein isolate). ''Certified Vegan'' is also claimed on the product label. The Supplement Facts panel and side panel discusses the presence of milk in the product.
Product label misprinted to include claim of ''No Dairy'', even though milk is present in an ingredient (calcium caseinate). ''Certified Vegan'' is also claimed on the product label. The side panel discusses the presence of milk in the product.
Planet Food is recalling Yum Nature Tahini because it has the potential to be contaminated with Salmonella.
Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
During a contracted state audit of the firm several insanitary conditions were found. These include a leaking roof and rodent activities. Some products showed evidence of filth.
In response to a FDA inspection, the firm initiated the recall because the product was found to be contaminated with Staphylococcus Aureus, E. Coli, and Alkaline Phosphatase.
Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient.
Cedarlane Natural Foods is recalling one specific lot of O Organics Black Bean Enchiladas because it contains undeclared milk.
Wira Corp. is recalling Jasmine Garlic Flavored Crackers because of undeclared colors FD& C Blue#1, FD & C Yellow # 5 , FD&C Yellow #6 and unapproved food color ingredients Ponceau 4R, E124, (Acid Red 18).
Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
The label does not identify all ingredients including a chocolate containing soy lecithin, a potential allergen.
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.