B Braun Medical Inc Recall 94890
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
B Braun Medical Inc Recall 94890 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2434-2024 |
| Event ID | 94890 |
| Event 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 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. International distribution to Canada. |
| Quantity | 9943 |
| Recall 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. |
| Device Classification | 20240731 |
| Device Code Info | Lot Code: Model No 8713031U; UDI-DI 4046964797958; All Serial Numbers |
| Center Classification Date | 20240725 |
| Recall Initiation Date | 20240614 |
| Recalling Firm | B Braun Medical Inc |
| Initial Notification | Letter |
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