B. Braun Medical Inc: Drug Recall

Recall #D-0434-2023 · 03/01/2023

Class II: Risk

Recall Details

Recall Number: D-0434-2023
Classification: Class II
Product Type: Drug
Recalling Firm: B. Braun Medical Inc
Status: Terminated
Date Initiated: 03/01/2023
Location: Irvine, CA, United States
Product Quantity: 30672

Reason for Recall

Subpotent Drug: low Anti-Factor IIa potency.

Product Description

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.

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.