Nixa, MO, United States
SPS Sterilization, Inc recalls
1 recall recorded since 2018, most recently on 7 March 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 March 2018
- Terminated
- 27 November 2018
- Reason
- 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
- US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3031-2018, Z-3030-2018, Z-3035-2018, Z-3029-2018, Z-3038-2018, Z-3037-2018, Z-3039-2018, Z-3041-2018, Z-3036-2018, Z-3028-2018, Z-3032-2018, Z-3040-2018 and 3 more
- Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
- Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
- Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
- Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
- Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
- Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
- Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
- Vascular Solutions Venture Rx Catheter, 6F, resterilized.
- and 7 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.