FT1000S FLUID TRANSFER SET — Class II medical device recall Z-0128-2024
Ongoing recall by B. Braun Medical, Inc., reported 2023-11-15, distributed nationwide. Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk
| Recall number | Z-0128-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2023-09-26 |
| Classified | 2023-11-03 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SG |
| Quantity | 24,400 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04022495769558 |
| Lot numbers | 0061755752, 0061761812, 0061766279 |
| Model numbers | 356048 |
Product
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
Reason for recall
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
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-0128-2024. 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.