B BRAUN MEDICAL INC: Drug Recall

Recall #D-0585-2025 · 08/04/2025

Class II: Risk

Recall Details

Recall Number: D-0585-2025
Classification: Class II
Product Type: Drug
Recalling Firm: B BRAUN MEDICAL INC
Status: Ongoing
Date Initiated: 08/04/2025
Location: Allentown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 74,088 containers

Reason for Recall

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Product Description

Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.

Distribution Pattern

Nationwide in the US

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.