Recall archive / FDA drug enforcement
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethl... — FDA record D-0076-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
- Reason
- Lack of sterility assurance: Bags have the potential to leak.
- Classification
- Class II
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 756 bags
- Agency-reported status
- Terminated
- Source record identifier
- D-0076-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: 0061832446 Exp. 31 Oct 2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
FL, NJ, PA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 14, 2022
- Recall initiation date
- Nov 25, 2022
- Center classification date
- Dec 5, 2022
- Termination date
- Aug 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.