Recalling Firm
Walter L. Shepeard Community Blood Center, Inc.
American Natl Red Cross Mid Atlantic Region
American National Red Cross Southeastern Michigan Region
Stryker Instruments Div. of Stryker Corporation

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

Distribution Pattern
Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
Worldwide Distribution -- AE, AO, AR, AT, AU, AZ, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CS, CZ, DE, DK, EG, ES, FI, FR, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LI, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, SY, TH, TN, TR, TW, UK, US, VE, and ZA.
Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
According to firm the distribution pattern is Virginia, West Virginia, Pennsylvania, and Maryland
Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
Worldwide Distribution - US Nationwide in the states of AR, CO, FL, GA, IN, KS, KY, MA, MI, NC, NE, NJ, NY, OH, OK, PA, TX, WA, WY and the countries of Canada, Europe, and Asia.
US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
Minnesota, North Carolina, Texas, New Jersey, Wisconsin
Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
Nationwide Distribution including KY, GA, MI, and NJ.
Worldwide Distribution-US (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, LA, MA, MI, MN, MS, MO, NE, NM, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, and WI, and the countries of AT (Austria), AU (Australia), BE (Belgium), CA (Canada), CH (Switzerland), DE (Germany), DK (Denmark), FR (France), GB (Great Britain), HK (Hong Kong), LB (Lebanon), NL (Netherlands), NZ (New Zealand), QA (Qatar), SA (Saudi Arabia), and SE (Sweden).
Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Tajikistan.
AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
Worldwide Distribution - US (Nationwide) and Internationally to ARGENTINA, BRAZIL, BULGARIA, CANADA, COLUMBIA, COSTA RICA, FRANCE, GERMANY, ITALY, MEXICO, GERMANY, ITALY, MEXICO, PANAMA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED ARAB EMIRATES, AND UNITED KINGDOM
Worldwide Distribution-US (nationwide) and internationlly to Canada
U.S. distribution to the following; CA, PA, VA, CT, MA, and NY. Foreign distribution to the following; Canada, France, UK, Germany, Italy, Serbia, Poland, Slovenia, Netherlands, Spain, and Peru
No US distribution. Worldwide Distribution to the countries of : Austria, Belgium, France, Germany, Great Britain, Greece, Italy, Netherlands, Poland, Romania, South Africa, Spain, Switzerland and Turkey.
AL, AR, CT, GA, MA, MD, MS, NC, NH, NJ, SC, TN TX and VA.
Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA and WI., and to the countries of : CHINA, PORTUGAL, CANADA, OMAN, MALAYSIA, NEW ZEALAND, INDIA, POLAND, LEBANON, SWITZERLAND, FINLAND, ROMANIA,UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, THE NETHERLANDS, ITALY, FRANCE, GERMANY, THAILAND,SAUDI, ARABIA, NORWAY and IRELAND.
Worldwide Distribution - US (nationwide) and Puerto Rico; internationally to Australia, Canada, Colombia, France, Germany, Great Britain, India, Italy, Mexico, Netherlands, Norway, Pakistan, Poland, Russia, Singapore, Spain, Switzerland, Thailand, and Zimbabwe.
Nationwide to wholesalers for further distribution at the retail level.

Product Description
Red Blood Cells Leukocytes Reduced Irradiated
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
BRAN Whole Foods Market Muffin Bran 6Pk packaged in clear plastic ''clam shell'' containers, NET WT. 12 oz., PLU 24857800499 Dist. by Whole Foods Market Austin, TX 78703
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
Blood and Blood Products for Reprocessing
Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
Desiccated Coconut Distributed by: Phildesco , Inc. Somerset, New Jersey 08873 USA
Red Blood Cells (Apheresis) Leukocytes Reduced
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
Garber's Old Fashioned Ice cream, Birthday Cake Flavored 1.75 quarts, packed in a shrink wrap of 3. #1 lot of 211/ 3 pk produced on 12/12/13 expires on 12/12/14 #2 lot of 451/3 pk produced on 3/31/14 expires 3/31/15 #3 lot of 454/3 pk produced on 11/5 14 expires on 11/5/15 1116 (three packs) = 3348 singles
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2.
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 &Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in the following Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
Hacizade Pismaniye Pashmak (Cotton Candy with Rose), Net Wt. 250-g (8.80-oz.), UPC 8697407913372
Brown Peeled and De-veined Shrimp, (U/10, U/12, 10/15, 16/20, 21/25, 26/30, 31/35, 36/40, 41/50, 51/60, 61/70, 71/80, 81/90, Large Pcs, Medium Pcs.) I.Q.F P&D Round T/ON Net Weight 3 Lbs. (48 oz.) in plain bag and master; 18 lbs. per case, 6 bags per case. Wild Caught Gulf Shrimp Packed For: Gerald Pockrus; Ingredients: Shrimp, Water, Salt, Sodium Bisulfite Present as a Preservative. Product of U.S.A.
Fresh Driscoll Strawberries, 8 x 16 oz. clamshell, 4 x 32 oz. clamshell. Keep refrigerated Driscoll's Strawberries, Watsonville, CA
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
Neusoft NeuViz 64 Multi-slice CT Scanner System
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure. The Camino catheter has a miniature transducer at the distal tip. This design eliminates the need for a fluid-filled system to carry pressure waves to an external transducer and thus, the problems inherent in such fluid-filled systems are eliminated. The Camino catheter is packaged with a zero adjustment tool which allows for the adjustment of the transducer during catheter preparation, and the LICOX Bolt Adapter Fitting. The Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma is clinically important. It is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Jose Madrid Salsa Mild NET WT. 13 OZ. (369 g.) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934 REFRIGERATE AFTER OPENING .0 93662 45252 2
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2 - 4), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
Lambda Cell Trays LCTW HLA CLass I (30T and 60T)-2 test tray 10-60 Well Tissue Typing Trays One Lambda, Inc. Canoga Park, CA 91303-2801 USA The LCT Class I trays contain T cell lymphocytes representing the HLA-A, and -C locus antigens from selected individuals in addition to negative and positive controls.
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information
Byrds Famous Cookies, Benne Bits, Net Wt. 6 oz. tins, UPC: 0-74882904651-8, Byrd Cookie Company, P.O. Box 1308, Savannah, GA 31416.
Byrds Famous Cookies, Vidalia Onion Biscuits, Net Wt. 3 oz. and 6 oz. tins, UPC: 0-74882904599-3 (6 oz) and 0-74882904605-1 (3 oz), Byrd Cookie Company, P.O. Box 1308, Savannah, GA 31416.
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT and X-Ray modalities for reference viewing. It support connectivity to ultrasound systems, PACS and other DICOM storage repositories.
NEXIUM (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.

Code Info
Only the BD Viper LT Systems, catalog number 442839, that utilize the CT/GC Assays are affected. Serial numbers VLT0040, VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, VLT0033.
#1 lot of 211/ 3 pk produced on 12/12/13 expires on 12/12/14 #2 lot of 451/3 pk produced on 3/31/14 expires 3/31/15 #3 lot of 454/3 pk produced on 11/5 14 expires on 11/5/15 1116 (three packs) = 3348 singles UPC# 0-28387-60068-2
Serial #: ALL HeartWare HVAD systems currently in use.
Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3
Code Dates: 0103910512, 0103910513, 0103910514, 0103910515, 0103910516, 0103910517, 0103910518, 0103910519.. Code breakdown: First 2 digits - Harvest location Next four digits: grower ranch number Final four digits: - Harvest date (month/day).
Catalog Identification: LCT1W30, lot # 027, batch 30-38 Catalog Identification: LCT1W60, lot # 027, batch 59-63
All product distributed between 08/18/2014 to 04/27/2015

Product Quantity
3095 total cases (8 x 1lb or 4 x 2 lb clamshells per crate.
121 units (30 in US and 91 international)

Reason for Recall
Blood products, which may have reached unacceptable temperatures during storage, were distributed.
Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper'' LT Instrument.
Incorrect labeling of the expiration date
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
CareFusion has identified an issue with the Alaris PC unit model 8015 software version 9.17 related to the cancel functionality that be used during atypical infusion programming to cancel user inputted values.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient, resulting in minor or potentially catastrophic injuries.
Desiccated coconut may be contaminated with Salmonella based on third party laboratory testing.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Firm voluntarily recalling 56 oz. Birthday Cake Ice cream due to adding the wrong ingredient into cake. (eggs added to cake) (undeclared egg allergen).
Blood product, collected from a donor with an unacceptable hemoglobin, was distributed.
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Source plasma product collected from a donor for which suitability was inadequately determined, was distributed.
Complaints with the HVAD Internal Controller Alarm Battery failures.
Plasma product, collected from a donor whose suitability to donate was not documented, was distributed.
The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.
complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.
Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
A manufacturing error at Hammond Enterprises Inc. (Medtronics supplier of the Passive Planar Probes) resulted in a lot of 50 devices where a Passive Planar Sharp Probe was assembled into a handle with a Passive Planar Blunt Probe part number.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Presence of 16255 - Ponceau 4R (E124) - Acid Red 18
Firm initiated a recall of certain codes dates of strawberries due to detection of the pesticide Naled at a level over the EPA tolerance of 1.0 ppm.
Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD-Solis pumps. Binding of the Cassette/ Keypad Lock can occur after latching the CADD-Solis Medication Cassette Reservoir or Administration Set disposable to the pump. When binding occurs, it can prevent the key from fully rotating the Cassette/ Keypad Lock to the locked (engaged) position. To start an infusion with CADD- Solis Pump Models 2111 and 2112, and Model 2120, when in PCA mode, the lock must be fully engaged. The CADD-Solis Pump Model 2120 will start in all other delivery modes without the Cassette/ Keypad Lock being engaged.
The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely. Failure is indicated by pin or ring artifact in the image
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Blood product, collected from a donor who lived in a malarial endemic area, was distributed.
A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter.
Misbranded red blood cells were distributed.
The firm was informed by the Ohio Department of Agriculture that product on the shelf was found with a convex lid.
Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
Lambda Cell Trays, with potential high background causing negative reactions to appear positive, were distributed.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written to a variable degree, with the result that it appears shifted from baseline on the system's output screen. This may, in turn, manifest as an uninterpretable ECG signal in the affected channel.
Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system.
Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent studies for other patients.
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM capsules contained 60 SEROQUEL XR tablets.