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

Agency Publication Date: September 20, 2018

Affected Products

Product: 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD

1724157464,1726253464, 1730452764,1800353664, 1732650264,1733152664, 1800353664,1801652764, 1804350264

Product: TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T

1733850164 1805050064

Product: 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD

1733152764 1806451564

Product: 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD

1733952664 1735258064

Product: P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS

1813600164

Product: P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS

1814906864

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80747

Status: Resolved

Manufacturer: COVIDIEN LLC

Manufactured In: United States

Units Affected: 6 products (27515 total)

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Sources: FDA iRES · Raw API Response

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