Recall Z-0819-2022 · MEA Pump, Infusion, Pca
B Braun Medical Inc
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
| Date | Feb 7, 2022 |
| Status | Terminated |
| Reason | Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion. |
| Root cause | Under Investigation by firm |
| Action | BBraun issued "URGENT MEDICAL DEVICE CORRECTION" letter on 2/7/21 to End-Users. Letter states reason for recall, health risk and action to take: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of theabove-mentioned product, and other concerned persons are informed about this voluntary correction. 2. Identify your current inventory of the affected serial (s) within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. 3. Utilizing the attached Product Correction Acknowledgement fo |
| Quantity | 6 units |
| Distribution | US Distribution to states of: MA, VT |
| FDA record | Open on fda.gov |