ParaPAC Plus 310 ventilator connector may detach and stop ventilation
Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall with structural device defect affecting core ventilation function; no reported illnesses or deaths per source, but serious injury potential to dependent patients justifies Severe per rubric.
Plain-English summary
Smiths Medical ASD Inc. is recalling the paraPAC Plus 310 ventilator kit with internal PEEP and CPAP (Item Number P310N). The company identified a potential issue where the patient outlet connector may loosen or detach from the device, which could interrupt active ventilation function in patients.
The affected devices were distributed worldwide. A total of 11,244 units are subject to this recall. Affected units have serial numbers ranging from 70 to 1801277; consult the FDA recall notice for the complete list of affected serial numbers.
Patients and healthcare providers using affected ventilators should immediately stop using the device if the patient outlet connector appears loose or detached. Contact Smiths Medical ASD Inc. for instructions on device replacement or repair.
The recalled product
- Product
- paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Ventilator
- Hazard
- ventilation-loss
- connector-detachment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 70
- 71
- 72
- 73
- 74
- 75
- 76
- 77
- 78
- 79
- 80
- 81
- 82
- 83
- 84
- 85
- 86
- 87
- 88
- 89
Distribution
Distribution scope not specified by the agency.
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