FDA Device recall Z-2434-2024
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Pr…
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Pr… by B Braun Medical, citing 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 syri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2434-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-14 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot Code: Model No 8713031U; UDI-DI 4046964797958; All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2434-2024%22
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