Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
USA Nationwide Distribution in the state of OK
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS).      Product Usage:  It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.
GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting ''Compare Study'' from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Current, Prior or Baseline), with a border color, and with Study Date anotation. The newest study is labeled ''Current'', the next newest study is labeled ''Prior'', and if there are 3 or more studies open the oldest study is labeled ''Baseline''. When viewing multiple studies simultaneously, the border color and ''Current''/''Prior''/''Baseline'' labeling may be incorrect.
Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3'' x 13.8'' x 18.1'' / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A.   The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P  Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA.    Used in direct monitoring of the partial pressure of oxygen.
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA.    Used in direct monitoring of the partial pressure of oxygen.
Integra Licox Brain Tissue Oxygen Monitoring  1 x Complete Brain Probe Kit  REF IP2.P    Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit   REF IT2     Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain  Probe Kit   REF IM3.SR     Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain  Probe Kit   REF IM1.S     Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit  REF IM2_EU     Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit  REF IM2.S_.EU     Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit  REF IM3.S_.EU     Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit  REF IM3.ST_.EU     Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany   Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA    Used in direct monitoring of the partial pressure of oxygen.
Blood product, with an unacceptable pH, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
Blood products, with outdated satellite bags attached, were distributed.
Worldwide Distribution - US (nationwide)  including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan,  Portugal, Saudi Arabia, Taiwan and Turkey.
Acuson SC2000 volume imaging ultrasound systems at software version 3.0.   Mfg name:  Siemens Medical Solutions USA, Inc.  Mountain View, CA 94043    Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.
Software issue results in inaccurate 3D image may result in ablation in wrong location.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated   The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
PIPELINE LS ACCESS SYSTEM, Holding Clip   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Coconut Tree Brand; Mut Gung Non; Ginger Candy; Ing:  Ginger, Sugar, Water Sold in 8 oz  sealed plastic pouches, and 12 oz sealed shrink wrapped plastic tubs.  P. By: E.T.I. San Jose, CA
California Department of Public Health tested Ginger Candy and found that it may contain as much as .012 ppm of lead.
Blood products, collected from a donor who had been incarcerated, were distributed.
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed.
Blood product, which was not quarantined subsequent to receiving post donation information, was distributed.
UNITRAC Pneumatic Retraction Arm.   A support arm used to hold surgical instruments during surgical procedures.
Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Community Blood Bank of Lancaster County Medical Society
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.
Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25.   Single-use 25 gauge cannula used in vitreoretinal surgery.
One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.
Blood product, collected from a donor who provided history that warranted a deferral, was distributed.
Blood products, labeled with an incorrect expiration date, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of:  China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical   Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.
Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
VARISOURCE Breast Template System for high-dose rate Brachytherapy.  ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer:  Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01001-4; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01007-6;  6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01013-7;  6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain-Club Pack, UPC 8-94700-10184-2
Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.
Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01031-1; 6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01037-3;  6/32 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01043-4
1,954 (6 oz) cases; (16 oz)  unknown cases; (32 oz) unknown cases
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01002-1; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01008-3;  6/32 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01014-4;  6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended-4 Value Pack, UPC 8-18290-01279-1
The Chobani Flip products come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack.   Chobani 0% Non-Fat Greek Yogurt Vanilla Golden Crunch-Flip, UPC 8-18290-01229-6
6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk Blended, UPC 8-94700-01045-8
6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk, UPC 8-94700-01048-9
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Honey Blended, UPC 8-94700-01003-8
6/4/3.5 oz. Chobani Bite 2% Milkfat Greek Yogurt Honey With Ginger, UPC 8-18290-01213-5
Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Fruit on the Bottom, UPC 8-94700-01004-5;   6/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-6 Value Pack, UPC 8-94700-01040-3;    6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-4 Value Pack, UPC 8-18290-01281-4
6/32 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Blended, UPC 8-94700-01026-7
6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Strawberry, UPC 8-18290-01261-6
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-94700-01032-8; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-18290-01280-7
8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Swirlin Strawberry Banana-Tubes, 8-18290-01207-4
3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Peach Blended-8 Value Pack, UPC 8-18290-01287-6
3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Blueberry Blended-8 Value Pack, UPC 8-18290-01288-3
Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages:   8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Jammin Strawberry-Tubes, UPC 8-18290-01204-3
Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.
Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages:   6/36/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes Variety Pack, UPC 8-18290-01230-2    6/16/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes, UPC 8-18290-01225-8;
The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid.  There are 12 containers per pack.   Chobani 0% Non-Fat Greek Yogurt Strawberry Sunrise-Flip, UPC 8-18290-01226-5
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom, UPC 8-94700-01005-2; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-6 Value Pack, UPC 8-94700-01041-0;  6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-4 Value Pack, UPC 8-18290-01282-1
Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages:   6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Blueberry, UPC 8-18290-01262-3;    Chobani Champions also comes in 3.5 oz plastic cups:    8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry-Tubes, UPC 8-18290-01205-0
6/16 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Blended, UPC 8-94700-01055-7
The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid.  There are 12 containers per pack.   Chobani 0% Non-Fat Greek Yogurt Blueberry Power-Flip, UPC 8-18290-01247-0
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach Fruit on the Bottom, UPC 8-94700-01006-9; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-6 Value Pack, UPC 8-94700-01030-4;  6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-4 Value Pack, UPC 8-18290-01284-5
6/16 oz. Chobani 0% Non-Fat Greek Yogurt Peach Blended, UPC 8-94700-01029-8
The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid.  There are 12 containers per pack.   Chobani 1.5% Milkfat Low-Fat Greek Yogurt Peachy Pistachio-Flip, UPC 8-18290-01248-7
15/6 oz. Chobani 0% Non-Fat Greek Yogurt, BB, Straw, Peach Fruit on the Bottom-15 Variety Pack, UPC 8-18290-01216-6
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Lemon Blended, UPC 8-94700-01009-0
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Fruit on the Bottom, 8-94700-01010-6; 6/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-6 Value Pack, 8-94700-01038-0;  6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-4 Value Pack, 8-18290-01285-2
6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Blended, UPC 8-94700-01046-5
6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Caramel w/ Pineapple Chunks-Bite, UPC 8-18290-01211-1
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Passion Fruit Fruit on the Bottom, UPC 8-94700-01011-3
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Fruit on the Bottom, UPC 8-94700-01012-0
6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Blended-4 Value Pack, UPC 8-18290-01276-0
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pomegranate Fruit on the Bottom, UPC 8-94700-01015-1
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Fruit on the Bottom, UPC 8-94700-01016-8; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-6 Value Pack, UPC 8-94700-01039-7;  6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-4 Value Pack, UPC 8-18290-01283-8
6/16 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Blended, UPC 8-94700-01056-4
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Apple Cinnamon Fruit on the Bottom, UPC 8-94700-01017-5
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Fruit on the Bottom, UPC 8-94700-01033-5
6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Blended, UPC 8-94700-01018-2
3/8/3.5 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango & Pineapple Blended-8 Value Pack, UPC 8-18290-01290-6
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blood Orange Fruit on the Bottom, UPC 8-94700-01034-2
6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Orange Vanilla, UPC 8-94700-01058-8
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended, UPC 8-18290-01274-6; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended-4 Value Pack, UPC 8-18290-01278-4
6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Fig with Orange Zest, UPC 8-18290-01210-4
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Banana Fruit on the Bottom, UPC 8-94700-01044-1
6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Banana Honey, UPC 8-94700-01052-6
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pear Fruit on the Bottom, UPC 8-18290-01202-9
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Apricot Fruit on the Bottom, UPC 8-18290-01258-6
12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry Fruit on the Bottom, UPC 8-18290-01259-3; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry on the Bottom-4 Value Pack, UPC 8-18290-01286-9
3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry & Blackberry Blended-8 Value Pack, UPC 8-18290-01289-0
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended, UPC 8-18290-01271-5; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended-4 Value Pack, UPC 8-18290-01275-3
The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid.  There are 12 containers per pack.   Chobani 1.5% Milkfat Low-Fat Greek Yogurt Key Lime Crumble-Flip, UPC 8-18290-01227-2
12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended, UPC 8-18290-01273-9 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended-4 Value pack, UPC 8-18290-01277-7
6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Raspberry with Dark Chocolate Chips, UPC 8-18290-01208-1
6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Coffee with Dark Chocolate Chips-Bite, UPC 8-18290-01209-8
6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Mint with Dark Chocolate Chips-Bite, UPC 8-18290-01293-7
6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Very Berry, UPC 8-94700-01049-6
4/4/3.5 oz. Champions 2% Milkfat Low-Fat Greek Yogurt Banana Honey & Very Berry-16 Variety Pack, UPC 8-94700-10102-6
Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages:   8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Flyin Dragon Fruit-Tubes, UPC 8-18290-01265-4    Chobani Champions product also comes in 3.5 oz. plastic cups:    6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Dragon Fruit, UPC 8-18290-01264-7;
Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages.   8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry-Tubes, UPC 8-18290-01206-7
Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages.   16/2.25 oz. Chobani Champions Tubes -1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry & Swirlin Strawberry Banana-Tubes Variety Pack, UPC 8-18290-01240-1
Greek yogurt product Chobani Champtions brand is recalled due to report of illnesses and product bloated and swollen.
The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid.  There are 12 containers per pack.   Chobani 1.5% Milkfat Low-Fat Greek Yogurt Almond Coco Loco-Flip, UPC 8-18290-01228-9
The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid.  There are 12 containers per pack.   Chobani 1.5% Milkfat Low-Fat Greek Yogurt Tropical Escape-Flip, UPC 8-18290-01249-4
The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid.  There are 12 containers per pack.   Chobani 1.5% Milkfat Low-Fat Greek Yogurt Nutty for Nana-Flip, UPC 8-18290-01260-9
Blood product, manufactured from an overweight whole blood unit, was distributed.
Blood products, collected using equipment for which quality control was not performed, were distributed.
Blood products, for which the quality control testing was incomplete, were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation information, were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716
Vinco's OsteoSheath Enhanced Bone Support, Calcium Supplement, 90 Tablets, distributed by Vinco, Inc., Evans City, PA;
The soy ingredient used to manufacture certain lots of Vinco's Osteosheath was potentially contaminated with Salmonella.
Vinco's OsteoSheath 4 Enhanced Bone Support, Calcium Supplement, 120 Tablets, distributed by Vinco, Inc., Evans City, PA
The soy ingredient used to manufacture certain lots of Vinco's Osteosheath 4 was potentially contaminated with Salmonella.
Vinco's Fem-Vite Women's Anti-Oxidant Formula, Dietary Supplement, 60 Tablets, distributed by Vinco, Inc., Evans City, PA
The soy ingredient used to manufacture certain lots of Vinco's Fem-Vite was potentially contaminated with Salmonella.
DANNON OIKOS Fruit on the Bottom GREEK NONFAT YOGURT BLUEBERRY 0% FAT
Expiration codes: 24 SEP 2013 PS and 25 SEP 2013 PS
OIKOS Nonfat Yogurt Blueberry Flavor Single Serve 5.3 oz cups were recalled because the lid correctly identifies the product but the cup is incorrectly labeled as blackberry flavor. Additionally, the product is blueberry flavored but the ingredient statement is for the blackberry flavor, which does not declare carmine, a potential allergen ingredient that is used in manufacturing the blueberry flavored product.
Distributed in Puerto Rico and US Virgin Islands.
SmartSet Endurance GMV, Gentamicin, REF 3105-040,  Medium Viscosity Antibiotic Bone Cement, Sterile.   SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.
The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potential risk. SmartSet GMV Endurance Gentamicin Bone Cement has only been cleared by the U.S. FDA for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Distributed in California, Oregon, Washington
Green Leaf Lettuce is sold in bulk cases under ''Garre Farms'' or ''Rossi Farms'' brand.  There are 24 heads of green leaf lettuce packed in each  cardboard box.   The Garre Farms brand is labeled in parts: ''***OREGON'S OWN!***Fresh Produce***GARRE FARMS, LLC***PORTLAND, OR 97230***PRODUCE OF U.S.A***''.    The Rossi Farms brand is labeled as ''***ROSSI FARMS***3701 N.E. 122nd AVE PORTLAND, OR 97230*** PRODUCE OF U.S.A.***''.
NONE.  No best by dates, no expiration dates, no lot codes.
Garre Farms is recalling green leaf lettuce due to a potential contamination with Listeria monocytogenes.
US Distribution including the states of  FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
FSE Image Upgrade Kit, Catalog # 92019C   This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC,  Milpitas, CA    The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA   The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA   The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA    The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900.   The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.
Some devices may be contaminated on the back side of the device with glue in the blood application area.
Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T    1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units)
There is a potential for water to collect in the vent pipe elbow in the magnet venting system.  Water may freeze, blocking the venting system.
STERRAD 100NX Cassettes   The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
Products sold to various accounts in Southern California and Arizona only.
Fruit Rush Black Cherry Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
All production dates from May 21 to September 16, 2013, UPC: 0-41900-07369-5.  Recall includes ''Best By'' dates through January 10, 2014.
The product has the potential to spoil prematurely.
Fruit Rush Fruit Punch Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
All production dates from May 21 to September 16, 2013, UPC: 0-41900-07362-6.  Recall includes ''Best By'' dates through January 10, 2014.
Fruit Rush Lemon Lime Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
All production dates from May 21 to September 16, 2013, UPC: 0-41900-07368-8.  Recall includes ''Best By'' dates through January 10, 2014.
USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part    Product Usage:    The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202.    The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
1,305 units total (654 units in US , 651 OUS )
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus.   The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008.  GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015
GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.
Strawberry Banana: GA.,MA.,CT.,AR.,NY.,NJ.,MD.,NH.,TX., CA., FL; Vanilla Almond: GA, NC.,MA.,CT.,AR.,NY.,RI.,NJ.,MN.,SC.,AZ.,OH.,MD.,IN.,NH.,TX. St. Thoms, USVI
NatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE VANILLA / ALMOND Dietary Supplement NET WEIGHT 3 LBS. (1362g).  Product Number:   9950
Undeclared allergens, milk,almond and soy.
NatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE STRAWBERRY / BANANA Dietary Supplement NET WEIGHT 3 LBS. (1362g).
US distribution including states of: MA, CT, NY.
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13
Specific error condition could lead to unintended laser emission during laser activation.
Products distributed in Illinois, Missouri, and Nebraska.
Frozen Sliced Carrots,  packaged in 2 lbs. bag, sold under Simplot Classic brand.  The UPC is 0 71179 1846 3 1.   The product is labeled in parts: ''***SIMPLOT CLASSIC***Sliced Carrots***NET WT 32 OZ. (2 LBS)***INGREDIENTS: CARROTS***KEEP FROZEN UNTIL READY TO USE. IF THAWED. DO NOT REFREEZE***Preparation Instructions***DISTRIBUTED BY: JR SIMPLOT COMPANY***BOISE, IDAHO 83707***PRODUCT OF U.S.A***''.
BEST BY SEP 2015/ 5M3 13X2L4  HH:MM.   Product  has Best By SEPTEMBER 2015.    The code 5M3 13X2L4  HH:MM  meant the product was repacked into Poly Bags on September 13, 2013, 07:47 am to 14:32 pm at NORPAC Foods, Inc., Quincy Foods, LLC Plant 2, 222 Columbia Way, PO Box 127, Quincy, WA 98848.
Green shelled soybeans (Edamame) are potentially mixed in with sliced carrots.
Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada
Alere Triage TOX Drug Screen Control 1   Product Generic Name: Quality Control Material    Description of the product:  Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment  of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control  procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures  described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results  obtained for the controls are to be compared with the assigned values given on the Expected Values Card,  accompanying the package insert, to determine if the procedure is within control limits.  Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of  human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse.    510(k)/IDE/PMA number: K060788    Type of Packaging: 5 vials per level in a labeled kit box.    Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.
Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.
US Distribution including the states of CO, VA, and MS.
Merit Medical Performa Angiographic Catheter 5F Multipack.  Part numbers 7560-43 and 7560-G3.
4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
Albuterol Sulfate Inhalation Solution, 0.083%  2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.