FDAMarch 7, 2018device
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
What to do
FDA enforcement status: Terminated
Brands named
sps sterilizationsps
UPCs
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABoston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.2018-03-07
- FDAEdwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.2018-03-07
- FDABoston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.2018-03-07
- FDABoston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.2018-03-07
- FDAVascular Solutions Venture Rx Catheter, 6F, resterilized.2018-03-07
- FDABoston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.2018-03-07
- FDABoston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.2018-03-07
- FDAEdwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.2018-03-07
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