FDA Recall D-0638-2024

B. Braun Medical Inc · Irvine, CA

Class I — life-threatening Ongoing 659 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, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

Lot / code: Lot #: J2L763, J2L764, Exp: 31 March 2025

Quantity: 63,444 containers

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-0638-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within U.S.A
Recall initiated: 2024-07-24
Classified by FDA Center: 2024-08-19
FDA published: 2024-08-28
Recalling firm: B. Braun Medical Inc
Firm location: Irvine, CA

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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