Recall Z-2436-2024 ยท FRN Pump, Infusion
B Braun Medical Inc
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
| Date | Jul 25, 2024 (initiated Jun 14, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On June 14, 2024, the firm notified customers via URGENT MEDICAL DEVICE FIELD CORRECTION NOTIFICATION letters. Customers were advised to not use the recalled syringes in Perfusor Space Syringe Pumps. All users should be informed of the correction. Customers were provided with an attachment to post in care areas as a reminder to not use the recalled syringes with the specified pumps. |
| Quantity | 930 |
| Distribution | Domestic distribution nationwide. International distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092313 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B.Braun Medical, Inc., Nov 4, 2009 |