Device product
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
Z-3206-2018
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
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.