FDA Recall D-0491-2025

B BRAUN MEDICAL INC · Allentown, PA

Class II Ongoing 332 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

Quantity: 187,656 containers

Reason for recall

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

Recall record

Recall number: D-0491-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-06-16
Classified by FDA Center: 2025-06-24
FDA published: 2025-07-02
Recalling firm: B BRAUN MEDICAL INC
Firm location: Allentown, PA

Drug identification

Brand name(s): SODIUM CHLORIDE
Generic name(s): SODIUM CHLORIDE
Manufacturer(s): B. Braun Medical Inc.
NDC(s): 0264-7800, 0264-7802
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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