B. Braun Medical Inc: Drug Recall

Recall #D-0370-2024 · 03/06/2024

Class II: Risk

Recall Details

Recall Number: D-0370-2024
Classification: Class II
Product Type: Drug
Recalling Firm: B. Braun Medical Inc
Status: Terminated
Date Initiated: 03/06/2024
Location: Irvine, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,752 bags

Reason for Recall

Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.

Product Description

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20

Distribution Pattern

Nationwide in the USA

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.