0 — Class II drug recall D-0549-2018
Terminated recall by B. Braun Medical Inc, reported 2018-03-07, distributed nationwide. Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethy
| Recall number | D-0549-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc, Irvine, CA, United States |
| Recall initiated | 2018-02-16 |
| Classified | 2018-02-27 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 17,360 plastic |
| Reason classes | specification failure |
| NDC | 00264-2201, 00264-2201-00, 00264-2201-10, 00264-2201-50, 00264-2201-70 |
| Lot numbers | J7N912 |
| Model numbers | R5200-01 |
| Expiration dates | 2020-10-31 |
Product
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
Reason for recall
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
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-0549-2018. 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.