FDA Drug recall D-0549-2018
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog…
- FDA Drug
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog… by B Braun Medical, citing 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 c….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0549-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-16 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
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
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.
Identifiers
| ndc | 0264-2201-00 |
|---|---|
| ndc | 0264-2201-10 |
| ndc | 0264-2201-50 |
| ndc | 0264-2201-70 |
| code_info | Batch # J7N912, Exp 10/31/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0549-2018%22
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