Recall Z-2619-2023 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
R A Medical Services
MINISCAV (tm) Vacuum Pump
| Date | Sep 20, 2023 (initiated Aug 23, 2023) |
| Status | Open, Classified |
| Reason | Inadequate documentation of acceptance activity |
| Root cause | Process control |
| Action | R A Medical Services notified the only consignee via email on 08/23/2023. Instructions were to quarantine and return affected units. |
| Quantity | 10 units |
| Distribution | Distribution to Ohio |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160950 | MINISCAV Sedation Systems, LLC, May 5, 2017 |