B. Braun Medical Inc.: Drug Recall

Recall #D-0916-2023 · 07/05/2023

Class II: Risk

Recall Details

Recall Number: D-0916-2023
Classification: Class II
Product Type: Drug
Recalling Firm: B. Braun Medical Inc.
Status: Terminated
Date Initiated: 07/05/2023
Location: Daytona Beach, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 79,880 bags

Reason for Recall

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

Product Description

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

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.