0 — Class II drug recall D-0655-2022
Terminated recall by B. Braun Medical, Inc., reported 2022-03-23, distributed nationwide. Lack of sterility assurance: leaking bags
| Recall number | D-0655-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2022-02-25 |
| Classified | 2022-03-17 |
| Reported by FDA | 2022-03-23 |
| Terminated | 2023-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 33,742 bags |
| Reason classes | sterility, packaging |
| NDC | 00264-7800, 00264-7800-00, 00264-7800-10, 00264-7800-20, 00264-7802, 00264-7802-00, 00264-7802-10 |
| Lot numbers | J1E086, J1E204, J1E213, J1H137, J1H138 |
| Expiration dates | 2023-05-31, 2023-06-30 |
Product
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Reason for recall
Lack of sterility assurance: leaking bags
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-0655-2022. 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.