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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 3390 of 3462

Product Firm Event Initiated
Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems Corporation Event 61479 June 18, 2012
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. Cardiovascular Systems, Inc. Event 62406 June 18, 2012
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems Corporation Event 61479 June 18, 2012
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems Corporation Event 61479 June 18, 2012
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems Corporation Event 61479 June 18, 2012
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems Corporation Event 61479 June 18, 2012
Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems Corporation Event 61479 June 18, 2012
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 Safe N Simple, LLC Event 80232 June 18, 2012
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Terumo Cardiovascular Systems Corporation Event 61479 June 18, 2012
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05, Stat Rx USA Event 62940 June 18, 2012
Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418. Ultradent Products, Inc. Event 62057 June 18, 2012
Frozen Oysters (IQF), Net Weight: 30 lbs (6/5lbs). J&S Group Event 62941 June 18, 2012
Rosati Cry Baby Sour Watermelon water ice, 6 fl oz SR Rosati, Inc Event 62417 June 18, 2012
Frozen Korean Oyster Meat I.Q.F.: , 1) 40x8oz., UPC 19964 30091; 2) 1x25lbs, .; 3) 5x4lbs.UPC 19964 30092 Red Chamber Company Event 62339 June 18, 2012
Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419. Ultradent Products, Inc. Event 62057 June 18, 2012
Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405. Ultradent Products, Inc. Event 62057 June 18, 2012
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits DeRoyal Industries Inc Event 62457 June 16, 2012
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants. Ge Healthcare It Event 64730 June 15, 2012
Alaris Pump Module Model 8100 (formerly Medley Pump Module) 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 62642 June 15, 2012
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Exactech, Inc. Event 62566 June 15, 2012
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty Exactech, Inc. Event 62566 June 15, 2012
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. Hitachi Medical Systems America Inc Event 62870 June 15, 2012
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Exactech, Inc. Event 62566 June 15, 2012
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Exactech, Inc. Event 62566 June 15, 2012
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7). Exactech, Inc. Event 62566 June 15, 2012

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