Outlook Safety Infusion System Y-type Blood Set — Class II medical device recall Z-0935-2020
Terminated recall by B. Braun Medical, Inc., reported 2020-02-12, distributed nationwide. Potential for leakage at the joint between the blood filters and tubing
| Recall number | Z-0935-2020 |
|---|---|
| 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 | 2019-11-20 |
| Classified | 2020-02-01 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2020-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,824 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04046955202799 |
| Lot numbers | 61679395, 61685454 |
| Model numbers | 477005 |
| Expiration dates | 2022-05-31, 2022-06-30 |
Product
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Reason for recall
Potential for leakage at the joint between the blood filters and tubing
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-0935-2020. 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.