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Recall Observatory FDA recall evidence

Device product

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

Z-3206-2018

July 11, 2018

Class II

Product summary

Firm
COVIDIEN LLC
Event
Event 80747
Status
Terminated
Classification
Class II
Quantity
27515 total
Official record key
device-enforcement:Z-3206-2018

Official wording

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

Code information: 1733952664 1735258064

Distribution pattern: The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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