Class II
Ongoing
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.
- Company
- B Braun Medical Inc
- Recall Initiated
- June 16, 2025
- Posted
- July 2, 2025
- Recall Number
- D-0491-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 187,656 containers
- Firm Location
- Allentown, PA, United States
Reason for Recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Distribution
USA Nationwide
Lot / Code Info
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
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