Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were 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 products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Blood products, collected from a donor who may have received a tattoo within one year of donation, were distributed.
Worldwide distribution: USA (nationwide) including states of:  AK, AR, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, KY, MA, MI, MN, MS, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, Puerto Rico, and countries of:  Argentina, Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Ecuador, Egypt, Germany, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Kuwait, Latvia, Malaysia, Mexico, Morocco, Panama, Puerto Rico, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
The product has the Catalogue/Part number 60010.   Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants.  A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers.  The Cool-Cap provides 72 hours of monitored cooling.     The device is labeled in parts: ''***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***''
The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants.  The visible clock displayed at the upper right hand corner of the screen stops advancing.
Distribution was made nationwide.  There was no foreign, military, or government distribution.
PrednisTab (Prednisolone, USP) 5 mg, packaged in 1,000-tablet bottles, For Oral Use in Dogs Only, RX, NADA #140-921, packaged under the following labels:   (1) Lloyd, Inc., Shenandoah, IA;  (2) Butler Schein Animal Health, Dublin, OH; and  (3) Phoenix, Manufactured for Clipper Distributing Company, LLC, St. Joseph, MO.
Some of the bottles may contain broken tablets
Distribution was nationwide, including Puerto Rico.  There was no foreign, military, or government distribution.
Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP Deviations; does not meet in process specification requirements
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01,   Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01,  Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01,   Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01,   Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01,   Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01,   Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution was nationwide.  There was no foreign, military, or government distribution.
LLOYD Thyro-Tabs (Levothyroxine sodium tablets, USP), 0.2 mg., packaged in 120-ct. (NDC 11789-252-10) and 1,000-ct. bottles (NDC 11789-252-20), RX, LLOYD, Inc., Shenandoah, IA..
Product lot KA16611 did not meet finished product release specifications
Levothyroxine sodium tablets, USP, 0.3 mg., RX, packaged under the following labels:   (1) LLOYD Thyro-Tabs, packaged in 120-ct. (NDC 11789-253-10) and 1,000-ct. bottles (NDC 11789-253-20), LLOYD, Inc., Shenandoah, IA;    (2) Butler Schein Animal Health Thyroxine L, packaged in 180-ct. (NDC 11695-4463-1) and 1,000-ct. bottles (NDC 11695-4463-2), Distributed Exclusively by Butler Schein Animal Health, Dublin, OH;    (3) Phoenix Thyrozine 0.3 mg., packaged in 180-ct. (NDC 57319-333-31) and 1,000-ct. bottles (NDC 57319-333-16), Manufactured for Clipper Distributing Company, LLC, St. Joseph, MO;    (4) VEDCO Thyrosyn .3 mg Tablets, packaged in 180-ct. (NDC 50989-201-86) and 1,000-ct. bottles (NDC 50989-201-53), Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed by VEDCO, INC., St. Joseph, MO.
Thyro-Tabs - KB15711, exp. SEP 2012;   Thyroxine L - KB13611 and KB13611A, exp. AUG 2012; and KB15711 and KB15711A, exp. SEP 2012;     Thyrozine - KB15711 and KB15711F, exp. SEP 2012; and KB13611 and KB13611A, Exp. AUG 2012; and    Thyrosyn - KB13611 and KB13611A, exp. AUG 2012.
Product did not meet in-process specification
Levothyroxine sodium tablets, USP, 0.7 mg.,RX, packaged under the following labels:   (1) LLOYD Thyro-Tabs, packaged in 120-ct. (NDC 11789-257-10), and 1,000-ct. bottles (NDC 11789-257-20), LLOYD, Inc., Shenandoah, IA;    (2) Butler Schein Animal Health Thyroxine L, packaged in 180-ct. (NDC 11695-4463-1) and 1,000-ct. bottles (NDC 11695-4463-2) , Distributed Exclusively by Butler Schein Animal Health, Dublin, OH;    (3) Phoenix Thyrozine 0.7 mg, packaged in 180-ct. (NDC 57319-337-31) and 1,000-ct. bottles (NDC 57319-337-16), Manufactured for Clipper distributing Company, LLC, St. Joseph, MO;    (4) VEDCO Thyrosyn .7 mg Tablets, packaged in 180-ct. bottles (NDC 50989-283-86), Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed By VEDCO, INC., St. Joseph, MO.
Thyro-Tabs - Lot KB18011, exp. OCT 2012;    Thyroxine L - Lot KB18011 and KB18011A, exp. OCT 2012;     Thyrozine - Lot KB18011, KB18011F, and KB18011FA, exp. OCT 2012; and    Thyrosyn - Lot KB18011 and KB18011A, exp. OCT 2012.
Levothyroxine sodium tablets, USP, 0.8 mg., packaged in 1,000-ct. bottles, RX, under the following private labels:   (1) Butler Schein Animal Health Thyroxine L, NDC 11695-4468-2, Distributed Exclusively by Butler Schein Animal Health, Dublin. OH; and    (2) VEDCO Thyrosyn .8 mg Tablets, NDC 50989-204-53, Manufactured by LLOYD, Inc., Shenandoah, IA,  Distributed by VEDCO, INC., St.  Joseph, MO.
Thyroxine L - KD11711, exp. AUG 2012; and   Thyrosyn - KD11711 and KD11711A, exp. AUG 2012.
LLOYD Thyro-Tabs (Levothyroxine sodium tablets, USP), 1.0 mg., packaged in 120-ct. (NDC 11789-268-10) and 1,000-ct. bottles (NDC 11789-268-20), RX.  The firm name on the label is LLOYD, Inc., Shenandoah, IA.
The tissues were shipped nationwide and to Canada and Korea.
Decellularized Dermis (Skin, human tissue for transplantation), product codes AFLEX100, AFLEX101, DCELL102, DCELL200, and DCELL251
Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Fascia, human tissue for transplantation, product code FL M
Bone, human tissue for transplantation, product code VG2C-T57, FIB4013, CAN90 410BP, CAN15 410BP, CAN90 14BP and CAN15 14BP.
Tendon, human tissue for transplantation,
Part One: CA, VA, VT, WI, OR, UT and Italy, Spain, Switzerland, France, Holland, Greece.  Part Two:  Dates of Distribution: 6/2512 - 7/27/12  Pattern: CA, NC, FL
Tumulo Farms, Pondhopper Cheese; any cut or partial wheels, wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA
State of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese. .
Shepherd's Way Big Woods Blue cut wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied.   Product is cut and packaged by Tomales Bay Foods, Petaluma, CA
Pack Dates of 6/28 and after; Make date of 7/19/11 to 7/27/11
State of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese.
Tomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese,  from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Ireland, Italy, Switzerland, France, Holland and Greece.  Varieties include Appalachian, Coolea, Cabot clothbound Cheddar, Big Rock Blue, Goat Gouda, Holey Cow, Big Woods Blue, Fiore Sardo,, Valdeon, Pecorino Romano, Sottocenere, Capriago, Capricious, Cave Aged Gruyere, Cave Aged Marisa, Fenacho, Pondhopper, Comte, L'Amuse Signature Gouda, Dante Waxed Rind, Dry Jack Special Reserve, Mezzo Secco,  Extra Mature Bandage Cheddar,  San Joaquin Gold, Flagship Reserve Truckle, Fontina Vallet Pietro, Grana Padano, Parmigiano Reggiano Organic,  Taleggio Organic,  Comte Reserve Ete, Loma Alta,  Mt. Viko Barrel Aged Feta,  Pepato, San Andreas Bellwether Farms, Reading, Tarentaise, Seahive, St. George, Toma and Wagon Wheel.  Cheese is cut per order and wrapped in cheese paper and marked with a magic marker indicating the type of cheese, poundage and pack date as well as a Tomales Bay Foods label. There are no code numbers or expiration dates marked on the product.
All product cut and wrapped on July 24 and 25, 2012.
562.74 pounds original recall, 101.1 pounds of Pondhopper and  31.41 pounds of Big Woods Blue
Firm received a positive environmental for Listeria Monocytogenes from their internal testing samples.
Nationwide distribution: US including states of: NE and SD.
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538   A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Merit's Custom Total Hip Pack, K12T-05537, Lot  numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
American Natl Red Cross Mid Atlantic Region
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products,  which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
Blood product, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Community Blood Centers of Florida, Inc.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Community Blood Centers of South Florida, Inc.
US distribution only: VA, MS, SC, AZ, TN, MI, TX, PN, CA, NY, CA, UT.
Vista System Version 3.2 service pack 3 used on Trima Accel Automated Collection System version 5.1 or User Defined Machines.  The software is used for determining donor eligibility based on annual Red Blood Cell Volume Loss Limits.
Vista Version 3.2 Service Pack 3 (stand alone Service Pack) part number 923000-326 and Vista V3.2 with Vista 3.2 Service Pack 3 (part number 923000-327B).
TerumoBCT Vista version 3.2 software, with a defect or glitch causing donors to be incorrectly deemed eligible, was distributed.
Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Miscalibrated and/or Defective Delivery System: Genentech has received complaints  for Nutropin AQ NuSpin 10 & 20  reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Blood product, which was incorrectly labeled as negative for the C red cell antigen, was distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with a low platelet count, was distributed.
Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI.  Internationally to  Australia,United Arab Emirates (UAE), Singapore, USA, Malaysia, BELGIUM, Japan, and CANADA.
24 Fr 8mm Sft Flow Str Wire W/L   The Sarns'' Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
catalog number: 5841 and 5845 and lot number: 0581536 and 0581138.
Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns'' Soft-Flow'' Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
24 Fr 8mm Sft Flow Straight Wir   The Sarns'' Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
catalog number: 5843 and lot number: 0584961
24 Fr 8mm Sft Flow Straight   The Sarns'' Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
catalog number: 5847 and lot number: 0582251 and 0586068
18 Fr 6mm Sft Flow Angled Wire   The Sarns'' Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
18 Fr 6mm Sft Flow Ang Wire W/L   The Sarns'' Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
24 Fr 8mm Soft Flow Ang Wire W/L   The Sarns'' Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
catalog number: 5762 and lot number: 0570466 and 0589212
24 Fr 8mm Soft Flow Ang W/L   The Sarns'' Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
catalog number: 5774 and lot number: 0595116.
The product has the potential to be contaminated with Salmonella.  The product was manufactured using peanut paste supplied by Sunland, Inc.
Cardiac Tissue Allograft, processed in a manner that did not prevent the introduction, transmission, or spread of communicable disease, was distributed.
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to Canada, AU, NZ, JP, DE, SA, and MY
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085)   The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources.  All lots of IRON Flex(R) reagent cartridges have the potential for this issue.  If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the magnitude of the elevation is consistent for all 15 tests in that well set.  The observed magnitude of the elevation ranges from approximately 20-800 ug/dL and the estimated rate is approximately 1 out of 2,500 wells.
Northern Illinois Blood Bank dba Rock River Valley BC
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, with a platelet count that exceeded the maximum specification, was distributed.
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS  REF 6543-1-600;NON-STERILE    Howmedica Osteonics Corp.  325 Corporate Drive  Mahwah, NJ  07430  USA  A Subsidiary of Stryker Corp.    Stryker France  ZAC Satolas Green Pusignan  Av de Satolas Green 69881 Meyzieu  Cedex France    The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.     Made in USA
Class I, 510(k) exempt   Catalog Number:  6543-1-600    Lot Number; NE1WR1
Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.
Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS    REF 6543-2-600;NON-STERILE     Howmedica Osteonics Corp.  325 Corporate Drive  Mahwah, NJ  07430  USA  A Subsidiary of Stryker Corp.    Stryker France  ZAC Satolas Green Pusignan  Av de Satolas Green 69881 Meyzieu  Cedex France    Made in USA  The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.
Class I, 510(k) exempt   Catalog Number:  6543-2-600    Lot Number: P1S43, P2A31
Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.
Siemens Mobilette Mira, intended use as Mobile x-ray system.
There is a risk of lost images during examination.
Nationwide distribution: USA including states of:   CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.
Siemens syngo.plaza Radiological Image Processing System   Usage: Radiological Image Processing System
Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction.  The Update Instruction SY050/12/S provides a software update and addresses the following issues:  - Patient Rename messages for the same patient are being continually processed for several days.  This fills up the 'pcvdbsrv' log and potentially affects performance of the system.  - Data could remain unprotected and not archived leading to a potential data loss.  - System crashes when user tries to delete a self created spine labeling step.  - For datasets with corrupt PR objects, not all images are loaded to Viewer and no Ferro message is displayed for the user.  - 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.  - Viewer crashes during load of next patient.  Error is related to 'Next Patient' from RIS.
Novarel (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0   Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ   07054    Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada.       NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label.  NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert.  NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall.
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Philips And Neusoft Medical Systems Co., Ltd.
Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501.  NeuViz Dual series CT Scanner System, part number 989605651321   The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach.  This issue may affect NeuViz Dual and NeuViz 16 scanners.
Transplant Services Center UT Southwestern Medical Center
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI.
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting.  This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (CREJ2), Urea (UREAL), C Reactive Protein (CRPL3).
Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use  for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201.    Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values with ''0'' standard reducing  the slope of the standard curve requiring more frequent sample dilutions.
Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Eastonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Lybia, Malta, Mexico, Netherlands, New Zealnd, Norway, Oman, Polnad, Protugual, Quatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Soth Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
Philips Digital Diagnost Software Version R2.0.2   Product Usage:  This system is used for making X-ray exposures for diagnostics
All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
With Digital Diagnost R2.0.2 a mirrored ''R in a circle'' is burnt into the image (if mirrored) in the lower right corner of the image.  When such an image is mirrored back inside the PACS system, an unmirrored ''R in a circle'' appears in the lower left corner.  This can be mistaken for a ''Right patient side'' marker, although this can appear on the left patient side.
traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI  48202; NDC 57664-377-18.
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Stryker Instruments Div. of Stryker Corporation
Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of  EEMEA, Canada, Latin America, and Japan.
Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents  Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg,   The Neptune Waste Management System consists of a mobile rover unit  used to suction and collect fluid waste, small debris and electrocautery  smoke from a surgical site. Mobility allows the rover unit to be  relocated to a waste disposal area where the rovers collection canisters  can be emptied, via the docking station.    Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.
Neptune 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents  Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg,     The Neptune Waste Management System consists of a mobile rover unit  used to suction and collect fluid waste, small debris and electrocautery  smoke from a surgical site. Mobility allows the rover unit to be  relocated to a waste disposal area where the rovers collection canisters  can be emptied, via the docking station.    Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
Zingerman's Bakehouse Gingerbread Cake Net wt. 3 LB; 1.25 LB
Zingerman's BAKEHOUSE pastry labels were found  not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Zingerman's Bakehouse Sourcream Coffeecake Net wt. 3 LB; 1.25 LB
Zingerman's Bakehouse Hot Cocoa Cake Net wt. 3 LB; 1.25 LB
Zingerman's Bakehouse Lemon Poppy Seed Coffeecake Net wt. 2.5 LB; 1.25 LB
Zingerman's Bakehouse Funky Chunky Chocolate Cookies Net wt. 3 ounces
Zingerman's BAKEHOUSE pastry labels were found  not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Zingerman's Bakehouse Funky Chunky Chocolate Cookie Jrs. Net wt. 6 ounces
Zingerman's Bakehouse Big O Cookie Net wt. 3 ounces
Zingerman's Bakehouse Big O Cookie Jrs. Net wt. 1/2 lb
Zingerman's Bakehouse Ginger Jump-up Cookies  Net wt. 3 ounces
Zingerman's Bakehouse Jr. Ginger Jump-up Cookies  Net wt. 6 ounces
Zingerman's Bakehouse Triple Trouble Chocolate Cookie  Net wt. 3 ounces
Zingerman's Bakehouse Junior Triple Trouble Chocolate Cookies  Net wt. 6 ounces
Zingerman's Bakehouse Mandelbread  Net wt. 8 ounces
Zingerman's Bakehouse Bumble Honey Cake  Net wt. 1.25 ounces
Zingerman's BAKEHOUSE pastry labels were found not identifying the source may contain butter and cream ingredients as milk and the source of flour as wheat.
Zingerman's Bakehouse Banana Bread  Net wt. 20 ounces
Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Zingerman's Bakehouse Genuine Ginger Brownies  Net wt. 1/4 lb
Zingerman's Bakehouse Country Scone  Net wt. 3 ounces
Zingerman's Bakehouse Ginger Scone  Net wt. 3 ounces
Zingerman's Bakehouse Northern Corn Bread  Net wt. 18 ounces
Zingerman's Bakehouse Currant Scone  Net wt. 3 ounces
Zingerman's Bakehouse Townie Brownies  Net wt. 1/4 lb
Zingerman's BAKEHOUSE pastry labels were found  not identifying the source of butter and cream ingredients as milk and lacking identity of soy allergen found in products.
Zingerman's Bakehouse Chocolate Banana Bread  Net wt. 20 ounces
Zingerman's Bakehouse Buenos Aires Brownies Net wt. 1/4 lb
Zingerman's Bakehouse Almond Pound Cake Net wt. 1.25 lb
Zingerman's Bakehouse Rugelach Net wt. 1/2 lb
Zingerman's Bakehouse Cinful Cinnamon Rolls Net wt. 1 1/2 lb
Zingerman's Bakehouse Brownie Party Net wt. 1.2 lb
Zingerman's Bakehouse Palmiers Net wt. 4 ounces
Zingerman's Bakehouse Summer Fling Coffeecake Net wt. 3 lbs
Zingerman's Bakehouse ZBPB's Peanut Butter Cookie Net wt. 3 ounces
Zingerman's Bakehouse Cape Cod Cranberry Walnut Pie
Zingerman's Bakehouse Chocolate Chess Pie
Zingerman's Bakehouse Olive Oil Cake Net wt. 1.25 lb
Zingerman's BAKEHOUSE pastry labels were found  not identifying the source of flour as wheat.
Zingerman's Bakehouse Graham Crackers 1 lb
Zingerman's Bakehouse Orange-Almond Magic Brownies 1/4 lb
Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Zingerman's Bakehouse Mary's Wild Oats Cranberry Almond Granola 1 lb
Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk.
Zingerman's Bakehouse Pecan Blondies 1/4 lb
Zingerman's Bakehouse Sweet Butter Teacake 1.25 lb
Zingerman's Bakehouse Nueske's Bacon Apple Coffeecake Net wt. 1.25 lb
Zingerman's Bakehouse Apricot Rugelach Net wt. 1/2 lb
Zingerman's Bakehouse Black Magic Brownies Net wt. 1/4 lb
Zingerman's Bakehouse Magic Brownies Net wt. 1/4 lb
Zingerman's Bakehouse Brownies -Magic & Black Magic (variety pack) Net wt. 1.2 lb
Nationwide Distribution including AZ, FL, MA,  NY, OH, and OR.
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC    The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; CO; MN; CA; IN; MD; MI; DC; GA; DE; CO; CT; WA; NJ; MD; TX; TN; MN; WA; CA; FL; OH; PA; NY; IN; OK; ID; IA; NY; WI; VA; CA; HI; MS; TX; HI; CT; TN; OR; WA; PA; NH; CA; MA; LA; IN; PA; AZ; GA; UT; ND; GA; TX; TX; IN; CA; MI; CT; CA; NC; MS; VA; IN; MI; NE; NV; MI; WA; IL; KY; LA; OR; OK; LA; TN; KY; TX; CA; PA; NM; NC; CO; DC; AL; MI; TX; SD; PA; OR; ID; NM; SD; CO; MN; NJ; MI; ND; MN; MT; LA; CT; WA; TX; IA; NJ; WI; SD; and UT, and the countries of Canada, Italy, Thailand, Russian Federation, Saudi Arabia, Slovenia, Singapore, Republic of Korea, Uzbekistan, Iceland, Israel, Austria, United Kingdom, Afganhistan, Japan, South Africa, Germany, Qatar, Netherlands, Switzerland, Denmark, and Sweden.
Invivo Corporation Expression MRI Patient Monitoring System.   The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached.  If this occurs, the cart can become unbalanced and may fall.
Nationwide Distribution including OH, NC, and NY.
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery  Product Number: 2001240 BiOM Charger
Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973
Battery may over-heat during charging and smoke
Connecticut, Georgia, Florida, Massachusetts, New Jersey, New York, Rhode Island and Wisconsin
Blue Diamond Almond Breeze Almond milk Half Gallon (1.89 L)  Paper Carton UPC: 4157005618
Product labeled as Unsweetened Vanilla Blue Diamond Almond Breeze Almond milk may contain chocolate flavored Almondmilk ( undeclared ingredients: cocoa and evaporated cane juice).
Nationwide in the US:  TX, MN, CA, LA, IL, AZ and Worldwide to Mexico.
Ground limestone also known as calcium carbonate. Omya's food grade ground limestone products. All bulk with no product labeling.    Product                       Container Size  Omya-Cal FG-10 AZ   50 lb. bags                                             2500 lb. bulk bags                                             2000 lb. bulk bags    Omya-Cal FG-4 AZ   50 lb. bags                                               Omya-Cal FG-15 AZ   2500 lb. bulk bags
Omya Inc. is voluntarily recalling certain lots of food grade ground limestone products processed at its Superior, Arizona plant because of the possible presence of Salmonella.
Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
USA Nationwide Distribution in the state of WI.
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant)   Product Usage:  The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Catalog Number: 113740 and Lot Number Identification: 779270
The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Listeria monocytogenes contamination in product
Chipotle Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Monterey Jack , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Mild Cheddar , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
United States distribution including CT, NJ, NY, GA, NC, SC, AL, TN, ME, MA, RI, LA, TX, AK, OK, CA, AZ, NV, HI, OR, WA, CO, KS, NM, UT.
Organic Gelato Chocolate Peanut Butter, 5 liter, contained in plastic packaging, manufactured by Fresca Foods, CO.
All products with a ''Best Buy'' date of 10/3/13 or earlier.
Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Serano Gelato Chocolate Peanut Butter, 16 oz, contained in a semiflexible paper container, manufactured by Fresca Foods, CO.
All products with a ''Best Buy'' date of 08/10/13 or earlier.
Elvis Ice Cream, 2.5 gallon, packed in a plastic container, manufactured by Fresca Foods, CO.
All products with a ''Best Buy'' date of 06/02/13 or earlier.
All Natural Boulder Ice Cream Peanut Butter Cup, 2.5 gallon, packed in plastic packaging, manufactured by Fresca Foods, CO.  All Natural Boulder Ice Cream Peanut Butter Cup, 1 pint, packed in semi flexible paper packaging, manufactured by Fresca Foods, CO.
2.5 gallon with a ''Best Buy'' date of 07/24/13 or earlier; 1 pint with a ''Best Buy'' date of 08/16/13 or earlier.
Yoki Bliss Peanut Butter frozen yogurt, 1 gallon, packaged in plastic containers, manufactured by Fresca Foods, CO.
Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia and Wisconsin.
Sara Lee Butter Streusel Coffee Cake, Net Wt. 11.5 oz ; 8 cakes per 5.75 lb case; Distributed by Sara Lee Corp., Downers Grove, IL 60515 U.S.A.; UPC: 032100023429
The retail packages of Sara Lee Butter Streusel Coffee Cake with UPC #3210002342 and a Best By Date of 10/16/2013 actually contain Sara Lee Pecan Coffee Cake, resulting in the undeclared allergen - pecans.
Beachside Produce is recalling iced broccoli crownds due to the potential of having hydraulic fluid onto the ice that cooled the product.
Distributed to Quality Food Centers (QFC) in Washington State and Oregon by common carrier.
Apple Lattice Pie (9-inch, 36oz).  Pies are sealed in a brown cardboard box with a see-through plastic label and sold as a fresh item at the consumer level.
Legendary Baking of Denver, CO is recalling 726 Private Selection 9-inch pies labeled as ''Apple Lattice'' with a UPC of 1111060195 and Lot Code 12296 (located on side of aluminum pie tie) because the pies may contain undeclared EGGS.  People who have an allergy or severe sensitivity to EGGS may run the risk of serious or life-threatening allergic reaction if they consume these products.
Sukhi's  Gourmet Indian Food; Red Curry Vegetables; 9 oz. package.  Manufactured by  Jagpreet Enterprises dba Sukhi's Gourmet Indian Foods; Hayward, CA 94545
A consumer complaint determined that some boxes of Red Curry and Vegetables were inadvertently packaged with Yellow Curry with Shrimp.