Reported Sep 26, 2018 · Terminated

400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code…

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?

  • 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Lot codes and dates
    • 1724157464
    • 1726253464
    • 1730452764
    • 1800353664
    • 1732650264
    • 1733152664
    • 1800353664
    • 1801652764
    • 1804350264
Amount recalled
27515 total

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

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

Notice updated Aug 3, 2020 · Data as of Sep 19, 6:03 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.