Community Blood Center of Greater Kansas City
Blood products, with invalid HIV/HCV nucleic acid testing (NAT) results, were distributed.
Blood products, collected from a donor who previously tested positive for Hepatitis B surface antigen (HBsAg), were distributed.
Blood products, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, collected from a donor who had not had an annual physical performed, were distributed.
Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria to be split unit, were distributed.
Blood product, collected from a donor whose physical examination was incomplete, was distributed.
Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE  MAT: 465 SS   The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
The tips of the drivers are breaking while being used to drive the screws into patients.
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE  MAT: 465 SS   The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Blood products, collected from donors whose arm preparation was inadequate, were distributed.
Blood products, collected from donors who were previously deferred for high risk behavior, were distributed.
Blood products, collected from a donor who may be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Product was distributed within the US to CA, FL and TX.  Government account:  Department of Defense, Camp Pendleton, CA.
FluMist, Influenza Virus Vaccine, Live, Intranasal, each 0.2mL dose is a suspension supplied in a single-dose pre-filled intranasal sprayer
FluMist, Influenza Virus Vaccine, Live Intranasal, lacking assurance of proper temperature manintenance during shipment, was distributed.
Mother's Milk Bank at Austin, Batch # 9429-1, 3 oz. (100 mL), Pasteurized, Exp: 3/25/2012, KCal/Oz: 20, Protein: .9 g/dl
The product had the potential to contain foreign materials.
Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.
Sarns Centrifugal System Control module, 100/115V   The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns  centrifugal system during cardiopulmonary bypass.
Sarns Centrifugal System Control module, 220/240V   The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Sarns Centrifugal System Control module System 9000   The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with platelet count below the specified minimum requirement, was distributed.
Blood and Blood Products for Reprocessing
The American National Red Cross - Southern Region
Blood products, collected from a donor who reported living in a malarial endemic area within the past three years, were distributed.
Blood products, collected from a donor who had been permanently deferred, were distributed.
Blood products, labeled with extended expiration dates, were distributed.
Sunquest Laboratory.   Sunquest Application Interfacing Outbound Department of Health Interface.
Sunquest Application Interfacing.  The standard Department of Health Template (conception date of 2/9/2005).
Software, with a defect or glitch, was distributed.
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16
United States Nationwide Distribution in the states of: CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL)   Product Usage: Enzyme n Immunoassay, Phenobarbital
Emit(R) 2000 Phenobarbital Assay (OSR4D229), lots 1151, 1167, 1191, and/or 1212 and Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots D4, D5, D6, and D7
Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems.  Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced.  Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be observed.  Firm has observed a low frequency of outliers that differ from the expected value by 20%.
Product is a 50% glycerinated Aspergillus niger (Human) Allergenic Extract in liquid form.  Product is vialed in 10 mL type 1 glass vials,stoppered with latex stoppers and sealed with a 13 mm aluminum crimped cap.
Mislabeled vials of Allergenic Extract were distributed.
Nationwide Distribution including NY, CA, ME and CT.
IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles.   The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States.  The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.
Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively
IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles.   The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
CA, IA, FL, MN, NC, NY, SC, TX Foreign: Canada, Columbia, Brazil, Ecuador, Guatemala, Hong Kong, Indonesia, Korea, Russian Federation, UK, Taiwan
Associates of Cape Cod Pyrotell Limulus Amebocyte Lysate (LAL) . In vitro diagnostic use to detect and quantify endotoxin gel-clot method Catalog Number: G5250-5: 5 vial Packs; Catalog Number: G5250-25: 25 vial Packs
217 (5 vial Packs) and 37 (25 vial Packs)
One lot of mislabeled Pyrotell gel clot LAL reagent was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Gourmet Firm Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz..  The product is sold under the Dae Han Tofu Soya Select brand.  The UPC is 0 34199 718903;
Soy was partially declared on the label because the ingredient list is cut off at the right side of the label.
Hot & Spicy Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz..  The product is sold under the Dae Han Tofu Soya Select brand.  Hot & Spicy Tofu has the UPC 0 34199 719191.
Wheat or Sesame Seed Oil was partially declared on the label because the ingredient list is cut off at the right side of the label.
Teriyaki Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz..  The product is sold under the Dae Han Tofu Soya Select brand.  The Teriyaki Tofu has the UPC 0 34199 718965.
Stir Fried Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz..  The product is sold under the Dae Han Tofu Soya Select brand.  Stir Fried Tofu has the UPC 0 31499 003283.
Nationwide to following states: MT, CA, AZ, PA, NC, TX, VA, IL, MI, CO, UT, GA, WA, WY, AK, FL, MO, ID.
Neera's Tikka Curry Rich and Creamy All Natural Simmering Sauce, 16 fluid ounces/ 473 ml. Packaged in jar. Packaged at 12/16oz units/case.   Product labeling reads in part:'' NEERA'S TIKKA CURRY Rich and Creamy All Natural Simmering Sauce***Just add meat, fish or vegetables!***16 Fluid Ounces / 473 mL***Manufactured by Cinnabar Specialty Foods, Inc. Prescott, AZ 86305  866 293 6433  www.cinnabarfoods.com***''.
The product was recalled due to undeclared sub-ingredients of milk and soy.
Mother's Milk Bank at Austin, Batch # 8638-1, 3 oz.(100 mL), Pasteurized, Exp: 02/19/2012, Kcal/Oz: 24,  Protein: 0.9 g/dl.
Mother's Milk Bank at Austin, Batch # 78501-1, 3 oz.(100 mL), Pasteurized, Exp: 06/28/2011, Kcal/Oz: 22,  Protein: 1.0 g/dl.
Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC.   Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Serial numbers AS180-00001 to AS180-00376.
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Nationwide; Also to Thailand, South Africa, Chile, Peru, Belgium, Bolivia, Ecuador, Uruguay. Mexico, China, Spain, Italy, Australia, France and Brazil.
MicroCel 500 Buffer Chamber   Mfg by:  Siemens Healthcare Diagnostics Inc., Berkeley, CA.
Catalog number 10312319/VG 42115 Product will have the letter R after the manufacture date.
Trugene MicroCel 500 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed.
Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.
Siemens syngo.plaza radiological image processing system.
Siemens became aware of an unintended behavior when using syngo.plaza.  In syngo.plaza within the online ''Short Time Storage'' (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.
Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.     Product Usage:  The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Baxter Interlink System Buretrol Solution Set, 117'' (3.0 m),  with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device;    Product Usage:  The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Baxter Clearlink System Buretrol Solution Set, 115'' (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.   Product Usage:  The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Baxter Clearlink System Buretrol Solution Set, 115'' (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device   Product Usage:  The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Nationwide distribution: USA including states of:  AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005.   Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Sterility of the product may be compromised.
Nationwide, Bahrain, Canada, China, Columbia, Germany, South Africa, Ireland, Japan, New Zealand, Norway, Peru, and South Korea
Single lot of Capture-R Ready Indicator Red Cells, which may result in higher rates for equivocal and unexpected positive reactions compared to other in-date or previously released lots, was distributed.
NY, NJ, PA, MA, VA, MD, CT, GA, IL, and TX
SooNyeoWon Soybean Sprouts (5 lbs., 10 lbs., and 16-ounce packages - all packaged in plastic bags). 16-oz bag UPC 0 28346 07121 8; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
10 pound bags (9207 units); 5 pound bags (1944 cases); 16 oz. - 2834 cases
Products have the potential to be contaminated with Listeria monocytogenes.
SooNyeoWon and Jinga brand Firm Tofu;  Net Wt. 16 oz., in square white plastic container, UPC 0 28346 07812 5 and  0 28346 09112 4, respectively.  Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
SooNyeoWon Firm Tofu -3437 cases;Jinga Firm Tofu- 3518 cases
Soy Milk, 1.3 gallon, packaged in a white plastic pail, UPC 0 28346 07140 9.  Produced by Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105.
SooNyeoWon Healthy Soybean Sprouts, 16 ounce package; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
SooNyeoWon and Jinga brand Soft Tofu 16 oz. in square, plastic containers, UPC 0 28346 07814 9 (SooNyeoWon).  Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
SooNyeoWon Silken Tofu; 14 oz. plastic container, UPC 0 28346 09113 1.  Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
SooNyeoWon  Silken Tofu - 140 cases; 697 units
Labeled in Korean as Healthy Tofu, 5-pieces and 10 pieces,  UPC 028346091292.  Manna Organics Inc. Newark, NJ.
Soon Tofu, 30-pieces packaged in large, white, plastic bucket.  Manna Organics Inc. Newark, NJ
Tofu Large Bucket  -3356 units; Soon Tofu-3150 units
Worldwide distribution: USA including AK, AL, AR, AZ, CA, CO, CT, DC
Battery, 100/115V (Includes charger and connecting cable)   The Sarns'' Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns'' Centrifugal System.  The reports can be broadly categorized as follows:  '' Failure to charge  '' Failure to hold charge  '' Failure to operate    In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In  this case, if the user doesn't clamp the venous line quickly enough, the patient could experience  hypovolemia. In the event of a backflow condition, air could become entrained in the arterial line,  which if not detected, could be passed to the patient.
Battery, 220V (Includes charger and connecting cable)   The Sarns'' Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Worldwide Distribution - USA including  Arkansas, California, Maryland, Mississippi, New York,  Pennsylvania and the country of Saudi Arabia
Caremor Cliner''***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***''   Literature:  ''***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners.  The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***''    Patient recliner chair
Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not ''snap'' onto a chair frame properly.
Caremor Cliner is labeled in part:  ''***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***''   Literature:  ''***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners.  The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***''  Patient recliner chair
Pico De Gallo in a plastic container labeled: ''Pineapple/Mango Pico De Gallo Roma Tomato, Pineapple, Mango, Red Onion, Green Bell Pepper, Anaheim Pepper, Cilantro Lime Juice, jalapeno Pepper, Salt  88694 83987  Keep Refrigerated  Best used by: 09/10/12 Packed by Spokane Produce, Inc 1905 S Geiger Blvd Spokane, WA 16 oz (454g)''
Daniella brand mangoes recalled because they may be contaminated with Salmonella.  Mangoes were used to manufacture Pico De Gallo.
florAlign Prebiotic Formula, sizes: 90g, 180g, 270g
UPC code #'s FA02-90GM, FA02-180GM, and FA02-270GM
Eco Health is recalling florAlign Prebiotic Formula because it has the potential to be contaminated with Salmonella.
Nationwide Distribution-including the states of FL, GA, IL, and NH.
TORQ Sternal Closure Device.  The common name is TWISTER, WIRE.  The model number is TQ01A.     The Catalog numbers are:  17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and,  15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile.    The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices).    This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.
Lot No. 062711.  Expiry date is June 2014.
The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.
Active Renin IRMA Kit, Part Number DSL25100   Product Usage:  The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes.  As a result, quality control and patient sample results may be falsely elevated by up to 72%.
Marte brand Frescolina Ricotta Salata. Matured and packed by: Fattorie Chiarappa SRL VIA Dell'ulvio, 5 Conversano (BA) - Italy. --- Product is vacuum packaged and is labeled with a round label. Product may also be cut into smaller wedges, but will still have the same Frescolina Ricotta Salata label.
Frescolina brand Ricotta Salata cheeses found positive for Listeria Monocytogenes resulting from CA state and FDA sampling.
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need.       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.
Eon Mini - 3788 (IPG), Multiple Serial Numbers
Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful.  SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.
Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY:  1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.   Orthopedic.  This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for  single use, this instrument may be re-used.
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.  An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY:  1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.   Orthopedic.  This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for  single use, this instrument may be re-used.
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY:  1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.   Orthopedic.  This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for  single use, this instrument may be re-used.
Worldwide Distribution-USA (nationwide) and the counties of  Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029.   The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: '' Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. '' Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.
Worldwide Distribution - USA (nationwide) and the following countries: Albania  Australia  Austria  Bahrain  Bangladesh  Barbados  Belarus  Belgium  Bosnia and Herzegovina  Bulgaria  Burundi  Canada  Chile  China  Colombia  Croatia  Czech Republic  Denmark  Ecuador  El Salvador  Finland  France  French Guiana  French Polynesia  Germany  Greece  Guadeloupe  Hong Kong  India  Indonesia  Iraq  Ireland  Israel  Italy  Japan  Kenya  Korea, Republic of  Kuwait  Libyan Arab Jamahiriya  Lithuania  Macao  Malaysia  Mexico  Monaco  Morocco  Namibia  Netherlands  New Zealand  Nigeria  Norway  Oman  Pakistan  Panama  Poland  Puerto Rico  Qatar  Reunion  Romania  Russian Federation  Saudi Arabia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sudan  Sweden  Switzerland  Taiwan  Turkey  United Arab Emirates  United Kingdom  Uruguay
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013.   Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
137,445 units total (26,155 units in US)
The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results.
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
TetraCXP Software System, Part Number A40051.   Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Organic Pine Nuts (Raw, No Shell) 1 lb.Nuts.com  NutsOnline, 125 Moen Street, Cranford, NJ 07016 800-558-8881
Color Cheddar Cheese Curds:    Springside Cheese, Color Curd,  55-0172,  V1, August 27, 2012,
Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012.  This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Springside Cheese, Color Cheddar,  55-0172,  V1, August 21, 2012,
Springside Cheese, Black Pepper  Color Cheddar,  55-0172,  V2, August 24, 2012,
Springside Cheese, Blue Cheese Color Cheddar,  55-0172,  V2, August 24, 2012,
Springside Cheese, Color Cheddar Horseradish Cheese,  55-0172,  V2, August 24, 2012,
Springside Cheese, Color Cheddar Tomato Basil ,  55-0172,  V1, August 21, 2012,
Springside Cheese, Monterey Jack Caribbean Red Hot ,  55-0172,  V3, August 28, 2012,
Springside Cheese, Monterey Jack  Chipotle Cheese,  55-0172,  V3, August 21, 2012.
Springside Cheese, Cranberry Monterey Jack  Cheese,  55-0172,  V3, August 28, 2012,
Springside Cheese, Monterey Jack Dill   Cheese,  55-0172,  V3, August 21, 2012,
Springside Cheese, Monterey Jack Habanero   Cheese,  55-0172,  V3, August 21, 2012,
Springside Cheese, Monterey Jack Jalapeno Cheese,  55-0172,  V3, August 21, 2012,
White Cheddar Cheese Curds:            Springside Cheese, White Curds, 55-0172,  V2, August 22, 2012,   NET WEIGHT___.
Springside Cheese, Maple White Cheddar, 55-0172,  V3, August 22, 2012.
Springside Cheese, Black & Green Olive White Cheddar Midget,   55-0172,  V3, August 22, 2012.
Springside Cheese, Reduced Fat  Farmers Cheese,  55-0172,  V2, August 21, 2012.
Springside Cheese, Reduced Fat Caraway Farmers,  55-0172,  V2, August 21, 2012.
Springside Cheese, Colby Cheese, 55-0172,  V3, August 27, 2012.
Springside Cheese, Bacon Colby   Cheese, 55-0172,  V3, August 27, 2012.
Springside Cheese, Morel & Leek Monterey Jack, 55-0172,  V3, August 28, 2012.
Springside Cheese, Monterey Jack Peppercorn Ranch , 55-0172,  V3, August 28, 2012.
Springside Cheese, Monterey Jack Roasted Red Pepper Cheese, 55-0172,  V3, August 28, 2012.
Springside Cheese, Monterey Jack Salsa Cheese, 55-0172,  V3, August 28, 2012.
Springside Cheese, rBGH Free White Cheddar, 55-0172,  V32 August 22, 2012.
Worldwide Distribution-USA (nationwide) and the countries of  Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.
Access Folate Calibrators, Part Number: A14207.   The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.
Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Access Folate WHO Calibrators, Part Number: A98033.   The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793.   Flowmeter, CM Assembly, Model#31970, Serial#13692.    Product Usage:    Conscious Sedation Unit Analgesia Gas Machine.
Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
CM Flowmeter Pkg H, Model #36700, Serial #  13749    Product Usage:    Conscious Sedation Unit Analgesia Gas Machine.
Worldwide Distribution - US Nationwide  and the countries of Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Finlind, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, India, Indonesia, Italy, Lebanon, Mexico, Netherlands, Norway, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, and Uruguay.
Triage TOX Drug Screen Panel, Model# 94400.   Product Usage:    The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
Frozen IQF PND Shrimp (Farm Raised), size 61/70 and size 71/90, 30 lbs (6bgsx5lbs)
Product has no lot numbers.  Product date: 15-11-2011.
Chang Jiang Seafood CA Inc. is recalling Frozen Shrimp because it contains nitrofuran which is an unapproved antibiotic.
Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Product is packaged in a glass jar with lid.    www.worldfiner.com  Product of Italy    UPC: 0 70670-00822 4
Da Vinci Pesto Genovese with Basil and Pine Nuts 10 oz. is mislabeled as the front of the label indicates pine nuts which was inadvertently omitted from the ingredient statement.
Marathon brand- 4 kilo boxes, label on the mango says ''MARATHON...PRODUCE OF MEXICO'', 952 ctns. of number 6 mangos, 714 ctns. of number 7's, 1186 ctns. of number 8's, 952 ctns. of number 9's, 714 ctns. of number 10's, 476 ctns. of number 12's.
GM Produce Sales is voluntarily recalling 4994 cartons of Marathon Brand mangos packed at Agricola Daniella, in Los Mochis, Sinaloa, because it has the potential to be contaminated with Salmonella gaminara, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
diet Orange Crush, no calorie orange soda, 2 L (2.1 QT), UPC 078000013979
Diet Orange Soda contains undeclared high fructose corn syrup.
Distributed to wholesale and retail customers in Alaska, Idaho, Montana, Oregon and Washington
Fruit Medley - 1) Zupan's brand Island Medley 12 oz UPC 92504723497  2) Mary's Select brand Island Fruit Medley - 12 oz UPC 9250473497  3) Mary's Select brand Fruit Mix Ensalada - 12 oz UPC 9250473216  4) Trader Joe's Plant Code: P-002 brand - Tropical Fruit Medley - 1 lb UPC 0094-9361
The mangos used to manufacturer the products may be contaminated with Salmonella.
Fruit Mango diced, peeled halves or spears   1) United Salad Co. brand Mango Diced 5 lb no UPC  2) United Salad Co brand Mango Peeled Halves 1 lb not UPC  3) Garden Highway Plant Code:  P-002 Mango Spears 24 oz UPC 826766-214068
Mango Salsa   1) Garden Highway Plant Code:  P-002 brand Mango Salsa 9 oz UPC 826766-422005  2) Mary's Select brand Tropical Salsa 16 oz UPC 9250474578  3) Mary's Select brand Tropical Salsa 16 oz UPC 9250474569  4) Garden Highway Plant Code:  P-002 brand Salsa Tropical Fresh 11 oz UPC 826766-422104
CANTALOUPE, HONEY DEW, PINEAPPLE AND GRAPES (CHPG) UNDER THE FOLLOWING BRANDS:   Indianhead   Foods 13105  FRUIT MIX CHPG 5#     Manufactured by Cut Fruit Express Mpls, MN 55076    Following products Distributed by H. Brooks & Co. Mpls, MN 55112:    H.Brooks & Company   31165  MIXED FRUIT CHPG  4/16OZ  16oz 4 per case UPC# 0 3823231165 6.       Festival Foods-Best Of The Season  31165   MIXED FRUIT CHPG  4/16OZ 16oz  4 per case  UPC# 0 3823231165 6.    Kitchen Cravings Kwik Trip #1 31595 FRUIT CUP MIX Chunks   5.5oz 24 per case UPC# 0 3977955262 5.       Kitchen Cravings Kwik Trip #31616 Fruit Tray 16 oz 12 per case UPC#0 3977955265 6.    Supermom's /Super America-Goodies-to go!   31595 FRUIT  MIX CHPG 5.5 oz 24 per case UPC# 76391390250 1.          H.Brooks    34382   MIXED FRUIT CHPG Net Wt 8 oz(227g)  6 per case 19 UPC# 0 3823234382 4.          H.Brooks 37663 FRUIT MIXED  CHPG  Net Wt 12oz(340g) 4 per case   175 UPC# 0 3823237663 1.
Cut Fruit Express, Inc  processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
CANTALOUPE:    UPPER LAKES Foods    142901   CANTALOUPE CHUNK  2/3#    UPPER LAKES Foods   142800   CANTALOUPE HALVED/PEELED 2/5# & 5#     USF   4259982   CANTALOUPE DICED 1/2'' X 1/2''  2/5# CCP       USF   4384418   CANTALOUPE CHUNKS 25#       USF   8138646   CANTALOUPE CHUNK 4/5#       USF   5985015   CANTALOUPE CHUNK 5#       USF   0900001   CANTALOUPE PLD & HALVED    10#    Manufactured by Cut Fruit Express, Mpls MN 55076.      The following products Distributed by H Brooks & Co Mpls MN 55112:    H.Brooks 37575   CANTALOUPE CHUNK Net WT 16 oz (454g)      4 per case   57 UPC# 03823237575 7.       H.Brooks    33326   CANTALOUPE CHUNK  5# Net Wt 80 oz (2268g)   1 per case   02 UPC# 0383233326 9.    Festival Foods-Best Of The Season H.Brooks    33326   CANTALOUPE CHUNK  5# Net Wt 80 oz (2268g)   1 per case   02 UPC# 0383233326 9.       H.Brooks 31931   CANTALOUPE FRUIT CUP 6/5.5   Net Wt 5.5oz(16g)   6 per case   164 UPC# 03823231931 7.    Festival Foods-Best of the Season 31931 H.Brooks 31931 CANTALOUPE FRUIT CUP 6/5.5   Net Wt 5.5oz(16g)   6 per case   164 UPC# 03823231931 7.    H.Brooks    37567   CANTALOUPE CHUNK 4/12OZ   Net Wt 12oz(340g)    4 per case   46 UPC# 0 3823237567 2.    H.Brooks    26868   CANTALOUPE SLICES Net Wt 10 oz (284g)    3 per case   214 UPC# 0 3823226868 4.         Reinhart Marshall     32774   CANTALOUPE DICE 40/1/2Cup     Net Wt 3 oz (85g)    40 per case  360  CCP.    Holiday Pantry   31561 Cantaloupe Chunks     Net Wt 5.5oz (156g)    24 per case   309 UPC# 0 3823231561 6.    Kitchens Cravings Cantaloupe    Kwik Trip    31561   CANTALOUPE  Chunks    5.5oz   24 per case UPC# 03977955259 5.
CANTALOUPE, HONEY DEW, GRAPES (CHG) UNDER THE FOLLOWING BRANDS:    USF  0811125  FRUIT MIX CHG RECEPTION  25#     Manufactured by Cut Fruit Express Mpls., MN 55076.    The following products Distributed By H. Brooks & Co. Mpls MN 55112:    Festival Best of the Season Medley Fruit Cup  H.Brooks 31907 Net Wt 5.5 oz. (156g) 6 units per case    158 UPC# 0 3823231907 2.    H.Brooks 31907 Medley Fruit Cup  Net Wt 5.5 oz. (156g) 6 units per case    158 UPC# 0 3823231907 2.    Holiday Pantry 32096 Fruit Medley Mix Net Wt 5.5 OZ (1256G) 24 units per case UPC# 0 3823232096 2.    H.Brooks 37647  MIXED FRUIT CHG  Net Wt 12oz( 340g)   4 per case   173 UPC# 0 3823237647 1.    Festival Foods-Best Of The Season H. Brooks 37655 MIXED FRUIT CHG Net Wt 16oz(454g)  4 per case 174 UPC# 0 3823237655 6.
CANTALOUPE, WATERMELON, HONEY DEW, RED GRAPES:    Festival Foods-Best Of The Season 30787 H.Brooks Melon Mix Slices Net Wt. 12 oz. (340g) 3 units per case   331 UPC# 0 3823230787 1.
CANTALOUPE, HONEYDEW, GRAPE, PINEAPPLE, STRAWBERRY:    Festival Foods-Best Of The Season  32299   H. Brooks FRUIT BOWL CHPGS  3#  Net Wt 48 oz (1362g) K280   2 per case UPC# 0 3823232299 7.    Distributed by H.Brooks & Co Mpls MN 55112
CANTALOUPE, HONEYDEW, PINEAPPLE AND RED GRAPE,  DIP:   H.Brooks 33478 FRUIT TRAY w/dip  2.5# Net Wt 40 oz (1134 g) 292   2 per case UPC# 0 3823233478 5.    H.Brooks 38279   FRUIT TRAY w/Dip 3# Net Wt 48 oz (1361g)    2 per case 101 UPC# 03823238279 3.    H.Brooks 38287   FRUIT TRAY w/Dip 2# DIP Net Wt 32 oz (907g)    4 per case 17 UPC# 0 3823238287 8.    Distributed By H. Brooks & Co. Mpls MN 55112
CANTALOUPE,  PINEAPPLE AND WATERMELON:   H.Brooks & Company   33531 FRUIT MIX  CPW SPEARS    15oz (425g) 4 per case UPC# 0 3823233531 7.        Distributed by H. Brooks & Co Mpls. MN55112.
CANTALOUPE,  HONEYDEW:   Festival Foods-Best Of The Season  46981   H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case  384 UPC# 0 3823246981 4.       H.Brooks 46981   46981   H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case  384 UPC# 0 3823246981 4.       Distributed by H. Brooks & Co. Mpls. MN 55112.
CANTALOUPE,  HONEYDEW, WATERMELON:   Festival Foods-Best Of The Season  37461 H. Brooks  Melon Medley Chunk  Net Wt 16 oz (454g) 4  per case  135 UPC 0 3823237461 3.       H. Brooks  Melon Medley Chunk  Net Wt 16 oz (454g) 4  per case  135 UPC 0 3823237461 3..            Distributed by H. Brooks & Co. Mpls. MN 55112.
Worldwide distribution -- USA (nationwide) and Internationally.
Reference materials ''RETINAL OCT Analysis and Interpretation Method'' shipped with iVue System (K091404) and the ''Retina Poster'' shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100;  The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA    The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, ''The Retina'' poster provided with the systems, and the book ''RETINAL OCT Analysis and Interpretation Method'' by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.
Worldwide Distribution--USA (nationwide) including the states of  AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and  Zimbabwe.
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL.   3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Model 5XL 1-door, serial numbers from 721799 - 722166.   Model 5XL 2-door, serial numbers from 820248 - 820285.    Model 8XL 1-door, serial numbers from 350608 - 350887.  Model 8XL 2-door, serial numbers from 450073 - 450105
3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
Product was shipped to the following states: AL, GA, IL, IN, KS, KY, MI, MO, NC, NE, OH, SC, TN, VA & WV.
FRESH SELECTIONS by Kroger'' Tender Spinach NET WT 10 OZ (283g) BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01 INGREDIENTS: SPINACH DISTRIBUTED BY THE KROGER COM. CINCINNATI OHIO 45202
BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01
The firm was notified by the Ohio Department of Agriculture of positive Listeria Monocytogenes in their Fresh Selection Tender Spinach.
Maryland Crab Cake Bulk (fresh), #81868, 4oz @2x8ct, Net Wt. 4 lbs, Packed by 3fish, Inc.
Item #79003, Lot #22YAW1A1235 (Diced Yellow Onions)
Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Charl Crab Cake Bulk (fresh), #81873, 2x8ct, 4 oz, Net Wt. 4 lbs, Packed by 3fish, Inc.
Item #79009, Lot #22YAW1A1235 (Diced Yellow Onions)
Crab Stuffing  Bucket (fresh and frozen), #84480, 5 lb Tub, Net St: 5 lbs, Packed by 3fish, Inc.
Item #79011, Lot #22YAW1A1235 (Diced Yellow Onions)
HT Signature Lump Crab Cake (Fresh), #81791, 4 oz @ 2x8ct, Net wt. 4 lbs, Packed by 3fish, Inc.
Item #79018, Lot #22YAW1A1235 (Diced Yellow Onions)
Carolina Style Crab Cakes (Frozen), 2 x 8ct  INGLES, Net Wt 4 lbs, Packed by 3fish, Inc.
Item #79035, Lot #22YAW1A1235 (Diced Yellow Onions)
Frozen Crab Bites,  oz, Bulk 100 x 0.5oz, Net Wt: 50 oz, Packed by 3fish, Inc.
Item #79037, Lot #22YAW1A1235 (Diced Yellow Onions)
MD Crab Cakes - Value Tray Pack (Frozen), 6  4x3oz, Customer Item: 504583, Packed by 3fish, Inc.
Item #79048, Lot #22YAW1A1235 (Diced Yellow Onions)
Harris Teeter, Atlantic Stuffed Salmon 8ct (Fresh)
Item #79202, Lot #22YAW1A1235 (Diced Yellow Onions)
Harris Teeter, Stuffed Tilapia 8ct (Fresh)
Item #79203, Lot #22YAW1A1235 (Diced Yellow Onions)
Harris Teeter, Stuffed Flounder 8ct (Fresh).
Item #79204, Lot #22YAW1A1235 (Diced Yellow Onions)
HT Premium Lobster Cake (fresh), 3 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc.
Item #79420, Lot #22YAW1A1235 (Diced Yellow Onions)
Jalapeno Salmon Cake 3oz (Fresh), 4 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc.
Item #79103, Lot #22YAW1A1235 (Diced Yellow Onions)
Initial distribution to: IL, MI, MN, ND, NY, NJ, SD, WI, IA, IN, OH and PA. Waiting for distribution information from firm.
Fresh Express Leafy Green Romaine; Crunchy Romaine Lettuce & Tender Green Leaf Lettuce  9 oz. bag, Keep refrigerated, no  preservatives.  UPC 71279-26112.  Fresh Express Incorporated  Salinas, CA.
Code: I246A5BMG, Use-By-Date: September 16, 2012.
USDA MDP program had a positive sample result for  Listeria Monocytogenes.
Minnesota, Iowa, North Dakota and Wisconsin
G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
SYSCO Imperial   47340104/5#    FRUIT MIX W/ORANGE WEDGES   130250 BEST BY 9/16/12, UPC# 0007 4865498029.
SYSCO Imperial   4835718   30/4.5 OZ  FRUIT MIX CANT/PINE/REDGRAPES   130249 & 130250   BEST BY 9/15/12 & 9/16/12.   SYSCO Imperial   7068657 4/5# FRUIT MIX    CANT/PINE/RED GRAPE   130250 BEST BY   9/16/12.
SYSCO Imperial   9498072   FRUIT W/GOLD PINEAPPLE KIT 4/1.5#   130250   BEST BY 9/16/12, UPC# 1007 4865871287.
SYSCO Imperial   1/5# PAIL MELON MIX HONEY-CANT W/ GRAPE 7225071   1/5#MELON W/GRAPE   130249 BEST BY 9/15/12, UPC# 0007 4865448475.
Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
Paddock Laboratories, LLC are recalling one lot  (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a  non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
3 PORT ''OFF'' MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655.    K914299.    Waste system.
Part Number (Item #) AG8049-NS, Lot # 2528655.
ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.