Recall Z-0163-2022 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Smiths Medical ASD Inc.
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
| Date | Jul 15, 2021 |
| Status | Terminated |
| Reason | Two devices were labeled with the same serial number |
| Root cause | Process control |
| Action | The firm notified the consignee by email on 07/15/2020 and requested the return of the units. |
| Quantity | 2 units |
| Distribution | UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123957 | PNEUPAC PARAPAC PLUS Smiths Medical International , Ltd., Sep 16, 2013 |