SPS Sterilization, Inc Recall: Edwards Lifesciences Thin-Flex Single Stage Venous Drainage
SPS Sterilization, Inc Recall: Edwards Lifesciences Thin-Flex Single Stage Venous Drainage is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: SPS Sterilization, Inc; Product: Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.; Rea
| Recalling firm | SPS Sterilization, Inc |
|---|---|
| Product | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US distribution to AZ, CA, FL, OH, PA, TX, VA, WV |
| Recall initiated | 20180307 |
| Recall number | Z-3030-2018 |
| Category | device |
| State | MO |
| Country | United States |
$29/mo
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