Reported Mar 27, 2024 · Ongoing
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
- Lot codes and dates
- Serial Numbers
3,621 of 3,621 codes
242242422513013522097710022501007181100718710091591009160100916110091621009163100918610091871009188100918910091901009230100923110092321009233100923410092351009236100923710092381009239101014310101441010145101014610101471010148101014910101501010151101015210101671010170101017310101741010175101017610113391011340101134110113421011343101134410113451011346101134710113481011349101135010113511011352101135310113541011355
- Serial Numbers
- Amount recalled
- 10140 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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