FDA Drug recall D-0112-2018
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc
- FDA Drug
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc by B Braun Medical, citing presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0112-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-15 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | B Braun Medical |
| Distribution | US |
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
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Identifiers
| ndc | 0264-2304-00 |
|---|---|
| ndc | 0264-2304-10 |
| code_info | Lot #: J7N965, Exp. 10/31/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.