Recall Z-3030-2018
SPS Sterilization, Inc · initiated March 7, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Codes / lots: Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16
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.
FDA-determined cause: Labeling False and Misleading
Action taken
Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.
Details
- Recall number
- Z-3030-2018
- Initiated
- March 7, 2018
- Terminated
- November 27, 2018
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 5 units total
- Distribution
- US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
- Recalling firm
- SPS Sterilization, Inc, Nixa, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3027-2018 Class II | Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3028-2018 Class II | Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3029-2018 Class II | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3031-2018 Class II | Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3032-2018 Class II | Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3033-2018 Class II | Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3034-2018 Class II | Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3035-2018 Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3036-2018 Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3037-2018 Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3038-2018 Class II | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3039-2018 Class II | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3040-2018 Class II | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |
| Z-3041-2018 Class II | Vascular Solutions Venture Rx Catheter, 6F, resterilized.The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | 03/07/2018Terminated |