Sterile IV Start Kits 50 units/trays per case Convenience kit for IV… — Class II medical device recall Z-0691-2017
Terminated recall by B. Braun Medical, Inc., reported 2016-12-07, distributed nationwide. Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finis
| Recall number | Z-0691-2017 |
|---|---|
| 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 | 2016-07-29 |
| Classified | 2016-12-01 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2018-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 15,950 units |
| Reason classes | sterility |
| Lot numbers | 361105 |
| Model numbers | 375198 |
| Expiration dates | 2017-01-01 |
Product
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Reason for recall
Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
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-0691-2017. 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.