Filtered Triple-Leg Extension Set — Class II medical device recall Z-1509-2021
Terminated recall by B. Braun Medical, Inc., reported 2021-05-05, distributed nationwide. BBMI has identified through complaints the potential for the extension set to become occluded or unable to pri
| Recall number | Z-1509-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-04-29 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2022-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,900 units |
| Lot numbers | 0061741483, 0061755034, 0061755296, 00SL713784 |
| Model numbers | 477034 |
Product
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
Reason for recall
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
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-1509-2021. 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.