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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3384 of 3462

Product Firm Event Initiated
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone Smith & Nephew, Inc. Endoscopy Division Event 62525 July 03, 2012
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone. Stryker Howmedica Osteonics Corp. Event 63273 July 03, 2012
Multiple lots of cheese produced by Andante Dairy, Petaluma, CA; Sold in 5 oz to 8 oz sizes with no code date or variety information on packaged. Varieties include: Largo, a triple-creme cow's milk, and Picolo, a triple-creme cow's milk. Also made with cow's milk: Pianoforte, Nocturne. Goat's milk cheese varieties: Acapella, Impromptu, Pastoral, Fresh Goat and Crottin, Minuet, a triple-creme goat's milk variety. Mixed Milk cheese varieties: Rondo, Metronome, Melange. Other varieties include Cavatina, Contralto, Vivace, Partita, Tri, Mini Alto, Figaro,Cadence Andante Dairy Event 62497 July 03, 2012
Romaine Lettuce tied with a rubber band Pacific International Marketing Event 62502 July 03, 2012
Fruiti Pops Coconut Ice Bars, 4 oz. Product labeling reads in part:" Fresh fruit bar Fruiti Pops Classic Coconut 4 FL OZ (118mL)***FRUITI POPS 15418 CORNET SANTA FE SPRINGS, CA 90670 PLANT NO. 06-4562***". Fruiti Pops Inc. Event 62491 July 03, 2012
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant Mc-NEIL-PPC, Inc. Event 62948 July 02, 2012
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders. Ethicon, Inc. Event 63254 July 02, 2012
Merge HEMO software. Merge Healthcare, Inc. Event 74577 July 02, 2012
Drager PT 4000 Phototherapy System Draeger Medical Systems, Inc. Event 62470 July 02, 2012
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate. Beekley Corporation Event 62432 July 02, 2012
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. Varian Medical Systems, Inc. Oncology Systems Event 62562 July 02, 2012
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes Philips Medical Systems (Cleveland) Inc Event 62498 July 02, 2012
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization. Transenterix, Inc Event 62583 July 02, 2012
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes. Greiner Bio-One North America, Inc. Event 62595 July 02, 2012
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0. ASTRA ZENECA Lp Event 62439 July 02, 2012
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia Hospira Inc. Event 62463 July 02, 2012
Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x 2 per carton: 8/10 oz and 10 oz/up c. 2lbs x 5 per carton: 2/3 oz d. 15lbs carton: 2/3 oz Product labeling reads in part:" T&T SWAI ROSE ROLL(Pangasius hypophtalmus)***FARM-RAISED PRODUCT OF VIETNAM***". Packaged in paper box carton. Nha Trang Seafoods, Inc Event 62762 July 02, 2012
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator Fujifilm Medical System USA, Inc. Event 67958 June 29, 2012
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed. Arjo, Inc. dba ArjoHuntleigh Event 62116 June 29, 2012
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags. C.R. Bard, Inc., Urological Division Event 62774 June 29, 2012
Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation. Arjo, Inc. dba ArjoHuntleigh Event 62116 June 29, 2012
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention. BD Biosciences, Systems & Reagents Event 62494 June 29, 2012
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates. CareFusion 303, Inc. Event 55121 June 29, 2012
Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation. Arjo, Inc. dba ArjoHuntleigh Event 62116 June 29, 2012
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 Mylan LLC. Event 62454 June 29, 2012

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