Z-1986-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 30, 2020
- Termination Date
- December 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3012 units
Product Description
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.
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Numbers: 1908700664, 1918351164