Bard 3F SL PowerMidline Full Kit CE-indicated for short term access… — Class II medical device recall Z-0295-2021
Terminated recall by Becton Dickinson & Company, reported 2020-11-04. Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural
| Recall number | Z-0295-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2020-09-14 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2021-11-09 |
| Countries outside the US | ES, GB, IT |
| Quantity | 72 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00801741141065 |
| Lot numbers | FEB-2022, MAR-2022, REEQ3598, REER0518 |
| Model numbers | P6153208 |
Product
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
Reason for recall
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
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-0295-2021. 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.