Recalling Firm
Philips Medical Systems North America Co. Phillips
Community Blood Centers of Florida, Inc.
Michael's Seafood Inc. DBA Michael's Gourmet & Delicacies
Horiba Instruments, Inc dba Horiba Medical
Udi's Healthy Foods,Granola & Gluten Free

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

Distribution Pattern
Nationwide distribution, including the states of NY, NJ, CA and FL.
Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand
Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
Allograft products were released for distribution to 6 consignees in US. located in CA, MD and PA.
Worldwide Distribution including Turkey, Greece, & Mexico.
Distributed in Mississippi and New Jersey.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Japan, Taiwan, Canada, United Kingdom, France, Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, Philippines and Brazil.
The product was distributed to IA, MO, NE, MN and WI.
Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
Sale of products through a network of independent distributors, preferred customers and end consumers in the United States, Japan, Australia and Mexico. Sales also directly to end consumers for personal consumption in Canada. Independent distributors consume the product themselves and in some cases sell the product or provide the product gratis to those potentially interested in LifeVantage. Preferred customers purchase the products on a monthly, auto-ship basis directly from Life Vantage. Other end consumers purchase directly from LifeVantage via the website and are assigned to a distributor.
Nationwide in the US, including the states of CA, MI, IN, FL, and GA.
Worldwide Distribution - USA (nationwide) and France.
Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.
Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,
Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.
199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.
Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA.
Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
US Distribution: 5 direct accounts in WA, CA, CO with subaccount distribution to WA, CA, CO, NV, UT, MT, ID, and OR.
US (nationwide) including the states of CA, FL, GA, OR and TN.
Nationwide Distribution to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI.
Alabama, Arkansas, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Montana, Missouri, Mississippi, Nebraska, North Carolina, New Hampshire, New Jersey, New York, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Washington, Virginia, Wisconsin and West Virginia
Distributed to UNFI distribution centers located in WA, CA, CO, and TX.

Product Description
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Leukocytes Reduced Irradiated
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Bone, Human Tissue allograft; CeSpace (Brand for Aesculap, Inc.); Prepared by Aesculap, Inc., Center Valley, PA and distributed by TBI National Processing Center, San Rafael, CA
Tendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA
Ultrafill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 1cc***Product Code: RT53001***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***TissueNet's Porcine DBM product line is used as a bone void filler
UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 5cc***Product Code: RT53005***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***TissueNet's Porcine DBM product line is used as a bone void filler.
UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 10cc***Product Code: RT53010***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***TissueNet's Porcine DBM product line is used as a bone void filler.
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits 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.
Platelets Pooled Leukocytes Reduced Irradiated
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel & Navigation ArmThe Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel & Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly.
Kentucky Bleu cheese was sold in the Louisville, KY, Whole Foods Market store, and was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Kenny's Farmhouse Cheese KY BL.
The Blue Kentucky Rose cheese sold in the Nashville, TN, Whole Foods Market store was cut and packaged in clear plastic wrap.It was sold with a Whole Foods Market scale label reading 'Blue Kentucky Rose Kenny's.
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
Publix 7 Yellow Special Blend Layers, Net Wt. 14.25 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
Publix 7 Chocolate Split Layers, Net Wt. 12.75 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
Alaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: MICHAEL'S WILD SOCKEYE SMOKED SALMON***INGREDIENTS: WILD ALASKAN SOCKEYE SALMON, SALT, SUGAR, NATURAL HARDWOOD SMOKE.***KEEP FROZEN UNTIL USE/THAWED UNDER REFRIGERATION IMMEDIATELY BEFORE USE.***DISTRIBUTED BY: MICHAEL'S SEAFOOD INC. 500 NE 185TH STREET, MIAMI FL 33179.***READY TO EAT WITHIN 3 DAYS AFTER OPENING OR BEFORE SELL BY DATE.***
Cherry tomatoes packaged in 1 pint clear, plastic clamshells. The clamshells are packaged either 9/1-pint clamshells or 12/1-pint clamshells per case.
TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR
TRIGAL***Pastelillos Coctel de Pizza (Pizza Mini turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Pak, CLINITEK ATLAS Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Protandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part:Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30 Caplets.
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Laparoscope, general&plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Udi's gluten free au naturel granola in 12 ounce clear plastic bag, UPC 6-98997-80615-8, best by 041913 12265 1.
Sam's Club Artisan Fresh Miniature Candy Cookie Carton 504 Count , 28.35 lb (12.89 kg)
FlowGate Balloon Guide Catheter,Manufactured by Concentric Medical, Mountain View, CA. FlowGate Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.
Yangsheng Duck Eggs Cooked Salted Duck Eggs Content:6 pieces Net Wt. 12.69 oz (360g)S & M (USA0 ENTERPRISE CORP. RED. B/T YUOXIU Bldg. 160-174 Lockhart Road, Man Chai, HK Distributed by: S & M INT'L. INC 100 Pulaski Street, Bayonne NJ 07002 UPC 6949682803568
Asian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD. BIN CHANH -HOCHIMINH CITY VIETNAM UPC 627404021822
Product labeled in part: ***PARAMOUNT RESERVE***PRODUCT OF CHILE FARM RAISED ATLANTIC SALMON PACKED BY: ALIMENTOS MULTIEXPORT S.A. *** DISTRIBUTED BY MULTIEXPORT FOODS INC. 703 WATERFORD WAY (NW 62ND AVE) SUITE 510, MIAMI, FL 33126***
Kinnikinnick Pie Crust Glutent Free (frozen) weight 290 g/ 10 oz Qty/Pkg: 2, UPC 620133006229, Kinnikinnick Foods 10940 120 Street, Edmonton, AB Canada.

Code Info
Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.
HS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A: 1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices. 2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices. 3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices 4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices. 5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices. 6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous. Laerdal is a distribution partner in EU and Canada, sold internationally
Code Number and Product Name: 0682000112-SPRING ARM, LIGHT 12-18KG, 0682000211 - FLAT PANEL SPRING ARM, ONDAL SUSPENSION, 15-21KG, 0682000212 - FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG, 0682000226 - SPRING ARM,3.5-7KG,NAVIGATION, 0682000228 - SPRING ARM, LIGHT 9-15KG, 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP, 0682001270 - 9-POLE SPRING ARM, AC 2000,15-21 KG, 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG, 0682400034 - FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG, 0682400059 - UNIVERSAL YOKE SPRING ARM RETROFIT KIT, 06824000591 - UNIVERSAL YOKE &amp;amp;amp;amp; SPRING ARM RETROFIT KIT, INT, 0682400151 - LOW CEILING SPRING ARM, 5P SIDE MOUNT, 0682400152 - LOW CEILING SPRING ARM, 9P SIDE MOUNT, 0682400169 - 5-POLE SPRING ARM AC 2000 9-15KG, CARDINAL, 0682400207 - STANDARD SPRING ARM WITH BEARING, 5P, 0682400208 - STANDARD SPRING ARM WITH BEARING, 9P, and 0682400365 - FLAT PANEL SPRING ARM WITH ERA ADAPTER BEARING.
The Kenny's Farmhouse Cheese KY BL has a PLU of 209578 and includes all 'sell by' dates, which are noted on the scale label.
The Blue Kentucky Rose Kenny's had a PLU of 71113 and includes all sell by dates, which are noted on the scale label.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3.
Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.

Product Quantity
United States: 1,082 units and Outside United States: 199 units
0 lbs - it was found that the TN store never received the recalled lots
283/9/1-pint clamshell cases and 190/12/1-pint clamshell cases
Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)
Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)
Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)
3510 - 12 ounce bags shipped (585 cases)
200 CASES (24 individual packages of 6 eggs each)

Reason for Recall
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor who disclosed taking Dapsone, were distributed.
Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
Blood product, collected from a donor who received a piercing within one year of donation, was distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who was permanently deferred, were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding high risk behavior, were distributed.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood products, collected using scales that did not meet the acceptable quality control specifications, were distributed.
Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
Complaints associated with an unexpected stop in AutoPulse compressions.
Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.
Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
.Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete engagement of the Spring Arm Circlip.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Blood product, which reached an unacceptable temperature during storage, was distributed.
Whole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KYstore and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky.
Zimmer Spine, Inc. is initiating a voluntary medical device correction to the Surgical Technique (L1607) for the TM Ardis Inserter because Zimmer has received complaints reporting difficulty in turning the implant release knob after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from the patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant from the inserter.
Product sample was found to be positive for Listeria monocytogenes.
Michael's Gourmet Delicacies, Miami, FL is recalling their Alaskan Wild Smoked Sockeye Salmon, Batch #1443 (4oz., 8 oz., 16 oz. and Trimmings) after a sample of 4 oz. Smoked Sockeye Salmon tested positive for Listeria Monocytogenes.
The recalled cherry tomatoes are associated with the Rio Queen Citrus, Inc. recall received on November 12, 2012 and used in the packaging of certain lots of Capital Brand Clamshell Cherry tomatoes have the potential to be contaminated with Salmonella.
Undeclared milk as the source of cheese.
When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
Possible inclusion of small metal fragments embedded within the tablets of Protandim Dietary Supplement.
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below.
Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.
Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be present. 2) If excessive torque is applied to assemble the post into the base, the PT Hybrid Glenoid Post drive tip could break off. 3) The PT Hybrid Glenoid Post may not thread at all into the Hybrid Glenoid Base, which would prevent assembly of the two implant components.
The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.
Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Sodium was not correctly stated on the label.
Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of the recall initiated in July, 2012 to include additional lots.
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Outer case of Sam's Artisan Fresh Miniature Candy Cookie contained White Chocolate Macadamia Nut Cookie and separate labels matching the White Chocolate Macadamia Nut Cookies.
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31.
Cooked Salted Duck Eggs have the potential to be contaminated with C. botulinum.
Tapoica stick contains undeclared sulfites.
The firm initiated the recall based on positive results for Listeria monocytogenes obtained from a composite sample tested by a private laboratory.
UNFI Aurora, Colorado is recalling certain Kinnikinnick Pie Crusts (frozen) because they were notified by the manufacturer, Kinnikinnick Foods (Alberta, Canada) that the products contain eggs and are not identified in the finished product labeling.