Reported Dec 9, 2020 · Ongoing
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage:…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
Capnostream 35 Portable Respiratory MonitorProduct numbers PM35MN02PM35MN01PM35MN05
- DLPM35MN02 - Product Usageuse during both no motion and motion conditions and for patients who are well or poorly perfused
- Lot codes and dates
- Serial numbersS
2,715 of 2,715 codes
SF16030134SF16240121SF16360313SF16450067SF17010227SF17010247SF17030358SF17050642SF17090981SF17110474SF17120491SF17140419SF17150846SF17180407SF17200722SF17240406SF18020067SF18020101SF18020103SF18030281SF18090439SF18090443SF18110356SF18271901SF18271902SF18271903SF18271904SF18271905SF18271907SF18271908SF18271909SF18271910SF18271911SF18271912SF18271913SF18271914SF18271915SF18271916SF18271917SF18271918SF18271919SF18271920SF18271921SF18271922SF18271923SF18271924SF18271938SF18271941SF18280055SF18301062SF18420402SF18430101SF18430150SF18430151SF18430154SF18430155SF18430156SF18430158SF18430159SF18430161
- Serial numbers
- Amount recalled
- 3217
Where it was sold
- Nationwide
Why it was recalled
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
This product could cause temporary or reversible health problems — stop using it.
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