B. Braun Medical, Inc.: Drug Recall

Recall #D-0655-2022 · 02/25/2022

Class II: Risk

Recall Details

Recall Number: D-0655-2022
Classification: Class II
Product Type: Drug
Recalling Firm: B. Braun Medical, Inc.
Status: Terminated
Date Initiated: 02/25/2022
Location: Allentown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 33,742 bags

Reason for Recall

Lack of sterility assurance: leaking bags

Product Description

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

Distribution Pattern

USA 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.