Home / Recalls / SPS Sterilization, Inc / Z-3030-2018

Z-3030-2018 Class II Terminated

Recalled by SPS Sterilization, Inc — Nixa, MO

Recall Details

Product Type
Devices
Report Date
September 19, 2018
Initiation Date
March 7, 2018
Termination Date
November 27, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units total

Product Description

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.

Reason for Recall

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.

Distribution Pattern

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

Code Information

Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16

Other recalls by SPS Sterilization, Inc

  • Z-3041-2018 Class II — Vascular Solutions Venture Rx Catheter, 6F, resterilized. (March 7, 2018)
  • Z-3036-2018 Class II — Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent (March 7, 2018)
  • Z-3032-2018 Class II — Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. (March 7, 2018)
  • Z-3034-2018 Class II — Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resteriliz (March 7, 2018)
  • Z-3029-2018 Class II — Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, (March 7, 2018)
  • Z-3040-2018 Class II — Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding St (March 7, 2018)
  • Z-3035-2018 Class II — Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary (March 7, 2018)
  • Z-3038-2018 Class II — Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM (March 7, 2018)
  • Z-3027-2018 Class II — Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. (March 7, 2018)
  • Z-3028-2018 Class II — Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. (March 7, 2018)