Recall Z-2974-2024 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Smiths Medical ASD Inc.
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
| Date | Sep 11, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 05/31/2024 by letter delivered via traceable means. The notice explained the issue, potential risk, and requested the following: "Customer Required Actions: 1. Identify all affected paraPac plus serial numbers in your possession. 2. Perform an inspection to determine if your devices are affected per the instructions below: a. Rotate the tidal volume knob to the lowest position of the control and evaluate whether or not the knob stays in position as set or if it moves to a higher position. b. Repeat this |
| Quantity | 10,240 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123957 | PNEUPAC PARAPAC PLUS Smiths Medical International , Ltd., Sep 16, 2013 |