FDA Drug recall D-1265-2014
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc…
- FDA Drug
- Class I
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class I recall of 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc… by B Braun Medical, citing presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1265-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-11-21 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Identifiers
| ndc | 0264-1800-36 |
|---|---|
| ndc | 0264-1800-31 |
| ndc | 0264-1800-32 |
| code_info | Lot# J2P912, Exp 02/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1265-2014%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.