Device product
Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Z-1989-2020
Product summary
- Firm
- Covidien Llc
- Event
- Event 85629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8162 units
- Official record key
device-enforcement:Z-1989-2020
Official wording
Reason: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Code information: Lot Numbers: 1909308664, 1909320964 1933802964
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment