FDA (Devices) recall action 80317
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
SPS Sterilization is recalling two Boston Scientific Wallstent tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life of the sterilization process.
SPS Sterilization, Inc. is recalling 10 units of resterilized Edwards Lifesciences Aortic Perfusion Cannulas because the expiration date on the labeling exceeds the validated shelf life.
SPS Sterilization is recalling two Boston Scientific Wallstent devices because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization, Inc. is recalling two units of resterilized Boston Scientific Wallstent Enteral Endoprosthesis because the expiration date on the labeling exceeds the validated shelf life.
SPS Sterilization, Inc. is recalling three Boston Scientific Wallstent RP Endoprosthesis tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life.
SPS Sterilization is recalling one unit of an Edwards Lifesciences Femoral Venous Cannula because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization, Inc. is recalling two Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stents because the expiration date on the labeling exceeds the validated shelf life.
SPS Sterilization is recalling 6 units of Edwards Lifesciences EZ Glide Aortic Cannulas because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization is recalling two units of resterilized Boston Scientific Wallstent RP Endoprosthesis because the labeling expiration date exceeds the validated shelf life.
SPS Sterilization is recalling 5 units of Avid Dual Stage Venous Drainage Cannulas because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization is recalling five units of Edwards Lifesciences venous drainage cannulas because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization is recalling one unit of an Edwards Lifesciences Femoral Venous Cannula because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization is recalling 10 units of resterilized venous drainage cannulas because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization is recalling 3 resterilized Venture Rx Catheters because the expiration date on the label exceeds the validated shelf life.
SPS Sterilization is recalling one resterilized Edwards Lifesciences Optisite Arterial Perfusion Cannula because its expiration date exceeds the validated shelf life.