Skip to content
Recall Observatory FDA recall evidence

Drug product

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.

D-0491-2025

June 16, 2025

Class II

Product summary

Firm
B BRAUN MEDICAL INC
Event
Event 97059
Status
Ongoing
Classification
Class II
Quantity
187,656 containers
Official record key
drug-enforcement:D-0491-2025

Official wording

Reason: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Code information: Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027

Distribution pattern: USA Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility