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 Monitor
    • Product numbers PM35MN02
    • PM35MN01
    • PM35MN05
  • DLPM35MN02 - Product Usageuse during both no motion and motion conditions and for patients who are well or poorly perfused
Lot codes and dates
  • Serial numbers

    2,715 of 2,715 codes

    • SF16030134
    • SF16240121
    • SF16360313
    • SF16450067
    • SF17010227
    • SF17010247
    • SF17030358
    • SF17050642
    • SF17090981
    • SF17110474
    • SF17120491
    • SF17140419
    • SF17150846
    • SF17180407
    • SF17200722
    • SF17240406
    • SF18020067
    • SF18020101
    • SF18020103
    • SF18030281
    • SF18090439
    • SF18090443
    • SF18110356
    • SF18271901
    • SF18271902
    • SF18271903
    • SF18271904
    • SF18271905
    • SF18271907
    • SF18271908
    • SF18271909
    • SF18271910
    • SF18271911
    • SF18271912
    • SF18271913
    • SF18271914
    • SF18271915
    • SF18271916
    • SF18271917
    • SF18271918
    • SF18271919
    • SF18271920
    • SF18271921
    • SF18271922
    • SF18271923
    • SF18271924
    • SF18271938
    • SF18271941
    • SF18280055
    • SF18301062
    • SF18420402
    • SF18430101
    • SF18430150
    • SF18430151
    • SF18430154
    • SF18430155
    • SF18430156
    • SF18430158
    • SF18430159
    • SF18430161
    S
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.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.