B. Braun Medical Inc: Drug Recall

Recall #D-0579-2023 · 05/09/2023

Class II: Risk

Recall Details

Recall Number: D-0579-2023
Classification: Class II
Product Type: Drug
Recalling Firm: B. Braun Medical Inc
Status: Terminated
Date Initiated: 05/09/2023
Location: Irvine, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,380

Reason for Recall

Subpotent: Low anti-factor IIa Potency.

Product Description

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain 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.