FDA Recall D-0628-2025

B BRAUN MEDICAL INC · Allentown, PA

Class I — life-threatening Ongoing 269 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

Lot / code: Lot #: V3K770, Exp 1/31/2026

Quantity: 47,148 containers

Reason for recall

Presence of Particulate Matter.

Recall record

Recall number: D-0628-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2025-08-18
Classified by FDA Center: 2025-09-10
FDA published: 2025-09-10
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
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

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

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