Recall Z-1274-2024 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Smiths Medical ASD Inc.
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
| Date | Mar 19, 2024 (initiated Feb 7, 2024) |
| Status | Open, Classified |
| Reason | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed. |
| Root cause | Under Investigation by firm |
| Action | Smiths medical issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 02/07/2024 via letter using traceable means. The notice explained the issue with the device, potential risk to the patient, and requested the following actions be taken: "There is no need to return or discontinue using your paraPAC plus, at this time. When using the device, all instructions, including warnings and cautions in the User Manual Doc. numbers (10018833-003 and/or 10026347-002) must be followed with heightened awareness. This is inclusive, but not limited to the following: " Constant monitorin |
| Quantity | 10140 units |
| Distribution | Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Cyprus, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Iceland, Ind |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123957 | PNEUPAC PARAPAC PLUS Smiths Medical International , Ltd., Sep 16, 2013 |