Drug recall
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per…
FDA recall event 97059 · Class II · B BRAUN MEDICAL INC
Key facts
| Event ID | 97059 |
|---|---|
| Recall numbers | D-0491-2025 |
| Recalling firm | B BRAUN MEDICAL INC |
| Product type | Drugs |
| Products | 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. |
| Initiation date | Jun 16, 2025 |
| Report date | Jul 2, 2025 |
| City | Allentown |
| State | PA |
| Country | United States |
| FEI number | 3013764800 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: