SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT — Class II medical device recall Z-0794-2022
Ongoing recall by Bard Peripheral Vascular Inc, reported 2022-03-23, distributed nationwide. Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
| Recall number | Z-0794-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2022-01-20 |
| Classified | 2022-03-16 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, HK |
| Quantity | 49,760 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10885403107771 |
| Model numbers | 4301CSP |
Product
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Reason for recall
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
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-0794-2022. 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.