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    Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GGP·April 11, 2012

    Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code OCX·February 17, 2015

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Recall
    Terminated ·Product code REK·January 31, 2020

    Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLH·October 18, 2013

    Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWF·December 30, 2009

    SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 9, 2012

    EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

    FDA Recall
    Terminated ·Edwards Lifesciences Research Medical Inc·Product code DWF·November 19, 2004

    Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The 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.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 23, 2014

    Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code DWF·April 27, 2006

    Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences

    FDA Recall
    Terminated ·Edwards Lifesciences Research Medical, Inc.·Product code DWF·April 18, 2006

    Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572. The TenderFlow (TM) Pediatric Arterial 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.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008

    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWF·October 7, 2010

    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWF·October 7, 2010

    Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

    Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

    Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

    Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L.

    FDA Recall
    Terminated ·Surge Medical Solutions, LLC·Product code DWF·April 17, 2007

    Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·May 9, 2008

    Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. long, with Xcoating" surface coating

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·February 23, 2012

    Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long, with Xcoating"surface coating Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·February 23, 2012