Class II — B Braun Medical Inc
| Recalling firm | B. BRAUN MEDICAL SAS |
|---|---|
| Registered facility | B. BRAUN MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A |
| Quantity | 4519 |
| Distribution | Domestic distribution nationwide. International distribution to Canada. |
| Initiated | 2024-06-14 |
| Classified | 2024-07-25 |
| Recall number | Z-2437-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — B Braun Medical Inc (Z-2437-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94890/
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