FDA-Device2018-09-26Class II
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
COVIDIEN LLC
Hazard
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Sold states
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.
Affected count
27515 total
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3206-2018Don't want to check this manually?
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