Recall Z-2972-2024 ยท FRN Pump, Infusion
B Braun Medical Inc
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
| Date | Sep 7, 2024 (initiated Aug 7, 2024) |
| Status | Open, Classified |
| Reason | Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected. |
| Root cause | Component design/selection |
| Action | On August 7, 2024, the firm notified customers via "URGENT MEDICAL DEVICE CORRECTION" letters which specified that previous recall RES 92978 had been extended to include additional serial numbers as well as one additional model number. The updated serial numbers for the prior models has been documented under RES 92978. This present record documents the addition of model number 8713050U. Customers were instructed to identify affected units in their facilities and to place the provided stickers on impacted units to aid clinical and biomedical staff in identifying units which require sensor exch |
| Quantity | 14 |
| Distribution | US distribution to AL, CA, GA, IL, MI, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191910 | SpaceStation MRI B. Braun Melsugen AG, Mar 12, 2020 |