B BRAUN MEDICAL INC: Drug Recall

Recall #D-0628-2025 · 08/18/2025

Class I: Dangerous

Recall Details

Recall Number: D-0628-2025
Classification: Class I
Product Type: Drug
Recalling Firm: B BRAUN MEDICAL INC
Status: Ongoing
Date Initiated: 08/18/2025
Location: Allentown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 47,148 containers

Reason for Recall

Presence of Particulate Matter.

Product Description

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

Distribution Pattern

U.S.A. Nationwide

Other Recalls by B BRAUN MEDICAL INC

Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

View all recalls by B BRAUN MEDICAL INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.