BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr… — Class II medical device recall Z-1983-2020
Terminated recall by Access Scientific LLC, reported 2020-05-20, distributed nationwide. Saline Flush Syringe compromised sterility due to holes in the packaging.
| Recall number | Z-1983-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Access Scientific LLC, San Diego, CA, United States |
| Recall initiated | 2020-04-23 |
| Classified | 2020-05-14 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 110 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10859821006237 |
| Lot numbers | 267011 |
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Reason for recall
Saline Flush Syringe compromised sterility due to holes in the packaging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1983-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.