B. Braun Medical, Inc.: Drug Recall

Recall #D-0076-2023 · 11/25/2022

Class II: Risk

Recall Details

Recall Number: D-0076-2023
Classification: Class II
Product Type: Drug
Recalling Firm: B. Braun Medical, Inc.
Status: Terminated
Date Initiated: 11/25/2022
Location: Allentown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 756 bags

Reason for Recall

Lack of sterility assurance: Bags have the potential to leak.

Product Description

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

Distribution Pattern

FL, NJ, PA

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.