Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP Recalled by Smiths Medical ASD Inc. Due to When a paraPAC plus ventilator is switched to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD Inc. directly.
Affected Products
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Quantity: 10140 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smiths Medical ASD Inc.
Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report