Device product
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Z-1986-2020
Product summary
- Firm
- Covidien Llc
- Event
- Event 85629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3012 units
- Official record key
device-enforcement:Z-1986-2020
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: 1908700664, 1918351164
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