0 — Class II drug recall D-0112-2018
Terminated recall by B. Braun Medical Inc, reported 2017-12-27, distributed nationwide. Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manu
| Recall number | D-0112-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc, Irvine, CA, United States |
| Recall initiated | 2017-12-15 |
| Classified | 2017-12-20 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2018-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,576 containers |
| Reason classes | specification failure |
| NDC | 00264-2304, 00264-2304-00, 00264-2304-10 |
| Lot numbers | J7N965 |
| Expiration dates | 2020-10-31 |
Product
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Reason for recall
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
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/D-0112-2018. 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.