Recall Z-3091-2024 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Smiths Medical ASD Inc.
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
| Date | Sep 20, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function. |
| Root cause | Other |
| Action | Smiths Medical issued an URGENT MEDIC AL DEVICE CORRECTION notice to its consignees on05/31/2024 via letter. The notice explained the issue, potential risk, and requested the following: "Perform an inspection to determine if your devices are affected, per the instructions below: a. First perform a visual inspection to determine if the outlet connector is disconnected. b. Second evaluate the connector physically to determine if the outlet connector is loose or moves when placing a patient circuit on the connector or when removing it. c. If outlet connector remains tight after physical inspec |
| Quantity | 3182 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123957 | PNEUPAC PARAPAC PLUS Smiths Medical International , Ltd., Sep 16, 2013 |