0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Reported: August 20, 2025 Initiated: August 4, 2025 #D-0586-2025
Product Description
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Reason for Recall
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Details
- Recalling Firm
- B BRAUN MEDICAL INC
- Units Affected
- 23,100 containers
- Distribution
- Nationwide in the US
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.. Recalled by B BRAUN MEDICAL INC. Units affected: 23,100 containers.
Why was this product recalled? ▼
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 20, 2025. Severity: Moderate. Recall number: D-0586-2025.
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