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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 11,244
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.
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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