B Braun Medical Inc: Device Recall

Recall #Z-2434-2024 · 06/14/2024

Class II: Risk

Recall Details

Recall Number: Z-2434-2024
Classification: Class II
Product Type: Device
Recalling Firm: B Braun Medical Inc
Status: Ongoing
Date Initiated: 06/14/2024
Location: Breinigsville, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9943

Reason for Recall

Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.

Product Description

Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A

Distribution Pattern

Domestic distribution nationwide. International distribution to Canada.

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.