Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor with non-confirmed repeat reactive HBsAg, was distributed..
Blood product,  which tested as CMV positive but labeled as CMV negative, was distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, which was collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood product, with a low platelet count, was distributed
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria for a divided unit, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, which was collected from a donor in whom donor suitability was not adequately determined, was distributed.
The product was distributed in the states of OH, PA, MI, NY.
Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped.  Date Codes 121401-130831
Peanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831
This product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella
Blood products, collected from a donor with an incomplete health assessment, were distributed.
Oregon, Washington, Arizona, Virginia, and Alabama.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected from  donors  with incomplete physical examination, were distributed.
Worldwide Distribution - 53 consignees out of the US.
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG,  Model 6788 Implantable Pulse Generator.
Model number 6788.  All lots manufactured prior to 03/16/2012 are being recalled.
Unintended Fluid ingress into the device header has been shown.
Genzyme Thymoglobulin [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC 58468-0080-01
Anti-Thymocyte Globulin (Rabbit) 25 mg, with an OOS assay result on the molecular size distribution stability test, was distributed.
Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico.
Orthofix ISKD Limb Lengthener Sterile Rx Only, Orthofix Inc. Lewisville, TX 75056.  ISKD - Intramedullary Skeletal Kinetic Distractor.   The ISKD is intended for limb lengthening of the tibia and femur.
There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.
Citalopram tablets USP, 10mg, 30-count bottle,  Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli,  India 502 325, NDC 55111-342-30
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli,  India 502 325, NDC 55111-343-30
Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli,  India 502 325, NDC 55111-344-30
Worldwide Distribution - USA ( nationwide)  including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of  Albania, Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Gibraltar, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Venezuela, Viet Nam & Yemen.
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
The low contrast pins in the Image Quality (IQ) phantom deteriorates over time.  This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3Model numbers 712020, 712022, and 712082   Product Usage:    Digital radiographic system
When the operator for a wall stand view selects an ''image rotation'' different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction.  When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Platelets Pheresis Leukocytes Reduced Irradiated
Interstate Blood Bank, Inc. of Wisconsin
Blood products, collected from a donor who was previously deferred, were distributed
Blood products, leukodepleted greater than three days after collection, were distributed.
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack,  UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.
Lot #s: a) NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT. b) NAA0TF3, NAA0TF2, NAA0TF0, NAA0TF1, NAA0TET, NAA0TEW, NAA0TEX, NAA0HHL, NAA0HHK, NAA0HHN, NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE, NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB, NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0, NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B, NAA03B8, NAA03B7, NAA02N1, NAA02LW, 244511P, 244501P, 244481P, 244471P, 244491P, 244451P.
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
Software anomaly.  Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260.  A component of the Computed Tomography X-Ray System.
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
PR Only (retailers at the north side of the Island)
''***Productos 2001**Plantillas para Pastelillos-Empanadillas-Tacos-Cheese Dog y Otros (dough rounds for tacos and turnovers)***18 units***Keep refrigerated***NET WT. 28 oz***''
Undeclared allergens: FD&C Yellow #5, Yellow# 6, Red #40.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
QuietCare-Networked product, Facility Server/model: QC101601;  The QuietCare system is intended  to detect and analyze residents' movements.
Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered.
ADM Alliance Nutrition Meat Goat Power 16%
During an FDA inspection, the ADM Alliance Nutrition Meat Goat Power 16% (80865AZN), was run through the firm's mixer directly after lot # BF23512 of the recalled sheep feed.  The Retention sample was found to have 46.4 ppm copper when the label states 25ppm-35ppm.
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
The product was distributed to stores in MO and an open farmer's market in gift baskets.  Exact dates of the start of distribution are not clear. The plastic packaging film used to package the recalled product is supplied by: Specialty Foods, Roland Park, KS.  The Annato cheese food coloring, cheese cultures and Rennet are supplied by, Dairy Connections, Madison, WI.
Homestead Creamery Artisan Cheese, Flory's Favorite, whole raw jersey milk, packaged in 1-lb or 1/2-lb block/plastic packs.
4/20-lb blocks cut into smaller 1-lb and 1/2-lb packages
The raw milk cheese product may be contaminated with shiga-toxin e-coli.
Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC  61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
Failed Dissolution Specifications; 36 month stability timepoint
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only,  Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
GE Healthcare Definium 5000 / 5220493 X-Ray System  This expected use for this product is intended to take  diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts.
It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.
GE Healthcare Definium 5000/5220493-2  X-Ray System  .This expected use for this product is intended to take  diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts.
Distribution was made to AR, AZ, AK, CA, CO, IA, IL, IN, KS, MI, MO, MN, NC, NE, NV, OR, TX, UT and WI.
3D White Arctic Fresh, 32 fl oz or 946 mL, whitening oral rinse, contains alcohol, distributed by Procter & Gamble, Cincinnati, OH.
Recalled products may have mixed during manufacturing process and products may appear cloudy and have sediment.
Scope Mouthwash, original mint, 1.5 L or 50.7 fl oz., distributed by Procter & Gamble, Cincinnati, OH.
Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
EXPAREL (bupivacaine liposome injectable suspension),  1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA
Lot #11-2005Control #23542 Manufacture Date: 05Dec11 2011-L-009
Arkansas, California, Colorado, Connecticut, Florida, Idaho, Kansas, Louisiana, Maine, Massachusetts, Nevada , New Jersey, New Mexico, New York, Oklahoma, Rhode Island, Texas and Utah.
Whole Foods Market Whole Catch Wild Alaskan Sockeye Smoked Salmon, Cold Smoked Sliced, Net Wt. 4 oz, Distributed by Whole Foods Market, Austin, TX 78703
UPC code 0 99482 40880 0, Lot codes 7425A2298B and 7425A2297A.  Sell by dates are applied at store level when product is thawed for sale and go 21 days out from date of thaw. Accordingly, the sell by dates should begin with 11/22/12 at the earliest and 2/15/13 at the latest.
The product has the potential to contaminated with Listeria Monocytogenes.
Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.
Clover sprouts, product is packaged in a 4 oz or 5 oz. clamshell containers, and 1 lb. bag or 2 lb. tray.  Product is sold under brand Sprouters Northwest. Clover Sprouts, 4oz container, has a UPC 8 15098 00201 6; Clover Sprouts, 5oz container, has a UPC 0 33383 70235 3; Clover Sprouts, 1 lb bag, has a UPC 0 79566 12351 5; Clover Sprouts, 2 lb tray, has a UPC 0 79566 12351 5;  The Clover Sprouts, 4 oz., Sprouters Northwest brand is labeled in parts: ''***CLOVER SPROUTS***Sprouters NORTHWEST***NET WT 4.0 oz***KEEP REFRIGERATED***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***''.   The Clover Sprouts, 5 oz., Sprouters Northwest brand is labeled in parts: ''***CLOVER ***Sprouters NORTHWEST, INC. KENT, WA 98032***NET WT 5.0 oz***KEEP REFRIGERATED***''.   The Clover Sprouts, 1 LB., Sprouters Northwest brand is labeled in parts: ''***CLOVER SPROUTS***NET WT. 1 LB***KEEP REFRIGERATED***Sprouters NORTHWEST, KENT, WA 98032***''.  The Clover Sprouts, 2 LB., Sprouters Northwest brand is labeled in parts: ''***Clover Sprouts***2 lb.*** Sprouters NORTHWEST, KENT, WA 98032***''.
The Best by Dates are including all and up to 2/17/2013.
14154/4 oz. Packages; 5130/5 oz. Packages; 24287/1 lb. Bags; and 552/2 lb. Trays
Clover sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Brocco Sprouts Sandwich Blend, packaged in a 4 oz. clamshell container, the UPC is 8 15098 00028 9.  The product is labeled in parts: ''***BROCCO SPROUTS SANDWICH BLEND***broccoli & clover sprouts***NET WT. 4.0 oz***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***www.BroccoSprouts.com***''Growers***Sprouters Northwest (Kent, WA)***''.
Brocco Sprouts Sandwich Blend are recalled due to a potential contamination with Listeria monocytogenes.
Spicy Sprouts, packaged in a 4 oz. clamshell container or 85 gram package.The product is sold under Sprouters Northwest or LifeForce brand.  The Sprouters Northwest, 4 oz., has UPC is 8 15098 00202 3.  The LifeForce, 85 gram, has  UPC 8 51042 00401 9.  The Sprouters Northwest, 4 oz., is labeled in parts: ''***SPICY SPROUTS***a blend of clover and radish sprouts***Sprouters NORTHWEST, INC.***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***SproutersNorthwest.com***''.  The LifeForce, 85 gram, is labeled in parts: ''***SPICY SPROUTS***a blend of clover and radish sprouts***LifeForce***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***''.
The Best by Dates are including all and up to 2/17/2013
7212/4 oz. Packages and 420/85 gram Packages.
Spicy Sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Alfalfa sprouts, packaged in a 4 oz. clamshell container or 85 gram package.Product is sold under Sprouters Northwest or LifeForce brand.  The Sprouters Northwest, 4oz., has UPC 8 15098 00108 8; The LifeForce, 85 gram, has UPC  8 51042 00402 6.  The Sprouters Northwest, 4oz, is labeled in parts: ''***ALFALFA SPROUTS***Sprouters NORTHWEST****KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***''.  The LifeForce, 85 gram, is labeled in parts: ''***ALFALFA SPROUTS***LifeForce foods***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***''.
14562/4 oz. Packages and 3024/85 g. Packages
Alfalfa sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Brocco sprouts is broccoli sprouts, packaged in a 4 oz. clamshell container or 85 gram package.  The Brocco sprouts, 4oz., distributed BRASSICA, has UPC 8 15098 00025; The Brocco sprouts, 85 gram, produced for LIFE FORCE, has UPC  8 51042 00400 2.  The Brocco sprouts, 4oz, is labeled in parts: ''***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT. 4.0 oz.***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***Growers***Sprouters Northwest (Kent, WA)***www.BroccoSprouts.com***''.   The LifeForce, 85 gram, is labeled in parts: ''***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT 85 g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***''.
792/4 oz. Packages and 528/85 g. Packages
Brocco sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Deli sprouts is a mixture of Clover, Fenugreek, Lentils, an Radish sprouts.  Product is packaged in a 4 oz. or 5 oz clamshell container. Product is sold under the Sprouters Northwest brand.  The Deli sprouts, 4 oz., has UPC 8 79566 12305 4. The Deli sprouts, 5 oz.,  as UPC  0 79566 12360 7.  The Deli sprouts, 4 oz., is labeled in parts: ''***DELI SPROUTS***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC.,  KENT, WA 98032***www.SproutersNorwthest***''.   The Deli sprouts, 5 oz., is labeled in parts: ''***DELI***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 5 oz.***Sprouters NORTHWEST, INC.  KENT, WA 98032***''.
Deli sprouts are recalled due to a potential contamination with Listeria monocytogenes.
3 Bean Munchies sprouts is a mixture of Green Peas, Cow Peas, Red Lentils and Garbanzo Beans.  Product is packaged in a 4 oz clamshell container and sold under the Sprouters Northwest brand.  Product has UPC 8 15098 00204 7.  The 3 Bean Munchies sprouts, 4 oz., is labeled in parts: ''***3 BEAN MUNCHIES***a blend of sprouts from green peas, cow peas, red and green lentils, and adzuki beans***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC.,  KENT, WA 98032***www.SproutersNorwthest***''.
3 Bean Munchies sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Mung Bean sprouts is packaged in a 8 oz clamshell container or 5 lb. bag and sold under the Sprouters Northwest or Life Force brand.   The Life Force foods, 8 oz,  has UPC 8 15098 00107 1; The Sprouters Northwest, 5 lb., has UPC 0 33383 70258 2.   The Life Force foods, 8 oz., is labeled in parts: ''***MUNG BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 4 OZ.***MANUFACTURED FOR: BRASSICA SPROUT GROUP, BALTIMORE, MD 21202***www.broccosprouts.com***''.   The Sprouters Northwest, 5 lb., is labeled in parts: ''***BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 5 LBS***Sprouters NORTHWEST***KENT, WA 98032***''.
Mung Bean sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Wheatgrass is packaged in a pint or cup, 16 oz. bag, or 5 lb. Flat cardboard box and sold under the Sprouters Northwest brand.  The Wheatgrass in a pint or cup has UPC 0 79566 12380 5; The wheatgrass in 16 oz. bag or 5 lb. Flat cardboard box does not have any UPC.   The wheatgrass, Sprouters Northwest, pint or cup., is labeled in parts: ''***Wheatgrass***CERTIFIED ORGANIC***Pint***Sprouters NORTHWEST, INC.***KENT, WA 98032***''.   The wheatgrass in 16 oz. bag is labeled in parts: ''***ORGANIC WHEATGRASS***SKU# 16OZCW***Keep Refrigerated***Not For Retail Sales as Packaged***''.   The wheatgrass in 5 lb. Flat cardboard box is labeled in parts: ''***Wheatgrass***1 Ea. 21''X21'' Wheatgrass/case***Item 40019***''.
3024/1 pint Packages; 888 cups; 63/16 oz. Bags; and 494/5 lbs. Flat boxes;
Wheatgrass is recalled due to a potential contamination with Listeria monocytogenes.
Organic Pea Shoots are  packaged in a 3 oz. or 4 oz packages.  Product is sold under the Life Force or Trader Joe's brand. The Life Force, 3 oz,  has UPC 8 51042 00414 9. The Trader Joe's, 4 oz, has UPC 0092 7567.   The Life Force, 3 oz, is labeled in parts: ''***Organic Pea Shoots***Life Force foods***KEEP REFRIGERATED***NET WT. 3.0 oz***DISTRIBUTED BY: LIFEFORCE FOODS, LLC***BALTIMORE, MD 21202***''.   The Trader Joe's, 4 oz,  is labeled in parts: ''***ORGANIC PEA SHOOTS***TRADER JOE'S***PERISHABLE, KEEP REFRIGERATED***RINSE BEFORE USING***NET WT. 4 OZ***SKU# 92756***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016***''.
The Best by Dates are including all and up to 2/16/2013
390/3 oz. Packages and 3180/4 oz. Packages
Organic Pea Shoots are recalled due to a potential contamination with Listeria monocytogenes.
Lions Eye Institute for Transplant & Research, Inc.
Indonesia; Egypt; Mexico; Saudi Arabia; Florida; Missouri; New Jersey; Dominican Republic
Human Corneas, recovered from a donor whose donor screening may have been performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
American Red Cross Blood Services Heart of America Region
Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed.
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates  the view restrictions dialog box only shows the top 12 restrictions.
Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.
VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage:  QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total.  Product Usage:  QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
USA Nationwide Distribution including the state of PA.
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components  Product Usage: Power injectable infusion PICC insertion kits
This recall is being initiated due to the affected product being packaged with the incorrect introducer needle.  The kit label indicates a ''safety'' needle is included; the kits were packaged with a non-safety needle.
SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
1BA67, exp Mar 13; 1DC02, exp Jun 13; 2BA86, exp Apr 14; 2FA92, exp Aug13.
The data suggests that the formulation does not support the shelf life of the product as labeled.
International distribution to the country of Australia.
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm.  The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use.  A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
Device Model #: 1 PMF 16-145-10CS.  Lot number: PFFB 190811.
A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages were identified prior to use.
Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of:  Australia, Lebanon, Germany, Spain, Sweden and Israel.
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700).   Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Catalog Numbers:  52-6800 & 52-6700;  All Lot Numbers
There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening.  Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Indiana Lions Eye and Tissue Transplant Bank
Human Corneas, recovered from a donor whose donor screening was performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
AL, FL, GA, MA, MD, NC, NJ, NY, PA, TN and VA
GoldCoast Salads Blue Crab Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Product may be contaminated with Listeria Monocytogenes
GoldCoast Salads Marine Lobster Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
GoldCoast Salads Lobster & Shrimp Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
GoldCoast Salads Smoked Salmon Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases.  This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Avex CX Suite, Avex CX 0.22 UL4,5 HK  REF #224-017,   Product Usage:  Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
Orthodontic brackets distributed was incorrectly labeled.
Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.
Stryker XIA 3 Iliac Screwdriver, 3-PCS.   The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. This device is not intended to sustain or support life.
Catalog Number: 48231326.  Lot Number:  10G637; 10G638 and 10E852.
Complaints have been reported indicating that surgeons have experienced unthreading of the screwdrivers outer shafts during use.
''Nationwide Distribution - One distributor in PA''
Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz..RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08  Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.
Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC.
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton.  Distributed by  McNeil-PPC Inc.
This product is not cleared for marketing in the US.
KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton.   Distributed by  McNeil-PPC Inc.
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it.  Distributed By: McNeil-PPC Inc.
Egyptian Parsley Flakes, Weight:  10kg Net.
Manufacturer's code:  Batch No. 127, Lot#.: 214   Specialty Commodities' Lot numbers:  SD28173, RE49421, SCS321167.
Specialty Commodities was notified by a customer that they had found Parsley Flakes to be positive for Salmonella.
Bream Dry Salted Fish Net Wt.: about 14.2 ozImported by Zip International Group LLC Product of Russia
NYSDAM sampling and analysis has revealed that Dry Salted Fish is uneviscerated.
Nationwide in the US:CA, NY, PA, NJ, MO, MA, OH, RI, CO, NC.  Worldwide in: Canada
Organic Lemon Grass Tea Bag Cut (TBC), Item#410. Packing Size:  25 kgs net double craft paper bags and double polyethylene bags each inner liner and repacked product packed in corrugated cartons with polyethylene inner liner.  Organic Lemon Grass Tea Bag Cut (TBC) bulk sold in original, repacked cases, and as component of blended bulk tea products.
QTrade Teas & Herbs is recalling Organic Lemon Grass Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.
Whole Foods Market Panettone Chocolate - 26.4 oz, 12 per case.
The reason for the recall was that a small portion of the Whole Foods Market Cranberry Panettone was mispackaged in Whole Foods Market Panettone Chocolate boxes. Allergens are declared on both labels, but the only difference is that soy is in the 'may contains' statement on Whole Foods Market Cranberry Panettone box and on the Whole Foods Market Chocolate Panettone box, soy is declared in the 'contains' box.
Worldwide Distribution - USA Nationwide including Canada.
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290) Product Usage:  Endoscopic Instruments - For use by, or as directed by, a surgeon in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar Cable - Monopolar electrosurgical current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon.
Integra has received complaint reports related to the electrical safety of the monopolar electrosurgical cables.
Shipped to one distributor who sold it to 15 restaurants all in Colorado.
Sold as In-House brand iced tea: Garbanzo Mediterranean Grill Organic Lemongrass Ginger Green Tea, 3 oz. packages
14 Pounds of 3 Ounce packages, 32 packs per case
Tea received from bulk supplier may be contaminated with Salmonella.
New York, Massachusetts, Pennsylvania, New Jersey, and Illinois.
Potato Dumplings, Net Weight 2 lb. (32 oz.), KEEP FROZEN, UPC 6 54368 10038 6, EST # A613069 --- JS Pelmeni OK - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490
The product contains undeclared milk and soy based on observations found during a joint inspection by the FDA and New York State Department of Agriculture & Markets.
Potato & Mushroom Dumplings, Net Weight 1 lb. (16 oz.), KEEP FROZEN, UPC 6 54368 10039 3 --- JS Pelmeni OK -  EST # A615133 - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490
UPC  6 54368 10039 3 and no other coding
GFS Lemon Pulling, Net Wt. 113 oz (7 lb 1 oz) 3.20 kg  UPC 93901-10676.  Distributed by Gordon Food Service, Grand Rapids, MI  49548.
Lot # 3T12354C printed on the end of can
Undeclared Milk Allergen.  GFS labeled Lemon Pudding  may contain vanilla pudding which contains milk.  The Lemon Pudding label does not list milk.
The Muffin Mam, Inc 24oz Strawberry Crme Cake, UPC 7-60366-00986-3
Mochiko Blue Star Sweet Rice Flour;Net Wt.  50 lbs.  (22.68 k)  Koda Farms Milling, Inc. South Dos Palos, CA 93665
Product code 3F13 and 3F14 (produced January 13 and 1, 2013.
Koda Farms received a report from a customer that a hard yellow material was found in rice flour dough that had been manufactured using rice flour supplied by Koda Farms.  The rice flour is believed to be the source of the foreign object.
Worldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA.
The MX 16-Slice 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.
Philips and Neusoft Medical Systems Co., Ltd. received a report from the field stating the four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
Ingenuity TF PET/CT Diagnostic imaging system
Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients.
USA Nationwide Distribution including the states of:  AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226  Product Usage:  Aesculaps Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12
AIC (USA) received a notification from Aesculap, AG (the manufacturer) regarding complaints that the bipolar energy did not stop after release of the foot pedal.
Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to  Canada
Technocut Plus,Sterile Single Use  Safety Scalpel, Distributed by: Myco Medial Cary, NC 27513.  The Technocut Plus Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology, and minor medical procedures.
Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Lot 13-121-JT* * the lot number may be followed by 01
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.