SPS Sterilization, Inc
Nixa, MO, US
SPS Sterilization, Inc appears in FDA device records in Nixa, MO. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 15 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 15
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3041-2018 | Vascular Solutions Venture Rx Catheter, 6F, resterilized. | 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. | Class II | Terminated | |
| Z-3040-2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized. | 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. | Class II | Terminated | |
| Z-3039-2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized. | 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. | Class II | Terminated | |
| Z-3038-2018 | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized. | 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. | Class II | Terminated | |
| Z-3037-2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized. | 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. | Class II | Terminated | |
| Z-3036-2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized. | 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. | Class II | Terminated | |
| Z-3035-2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized. | 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. | Class II | Terminated | |
| Z-3034-2018 | 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 process used does not have adequate support for the extended shelf life. | Class II | Terminated | |
| Z-3033-2018 | 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 process used does not have adequate support for the extended shelf life. | Class II | Terminated | |
| Z-3032-2018 | Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. | 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. | Class II | Terminated | |
| Z-3031-2018 | Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized. | 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. | Class II | Terminated | |
| Z-3030-2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized. | 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. | Class II | Terminated | |
| Z-3029-2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized. | 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. | Class II | Terminated | |
| Z-3028-2018 | 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 process used does not have adequate support for the extended shelf life. | Class II | Terminated | |
| Z-3027-2018 | 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 process used does not have adequate support for the extended shelf life. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain