B Braun Medical Inc: Device Recall

Recall #Z-2972-2024 · 08/07/2024

Class I: Dangerous

Recall Details

Recall Number: Z-2972-2024
Classification: Class I
Product Type: Device
Recalling Firm: B Braun Medical Inc
Status: Ongoing
Date Initiated: 08/07/2024
Location: Breinigsville, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14

Reason for Recall

Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

Product Description

Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

Distribution Pattern

US distribution to AL, CA, GA, IL, MI, and TX.

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.