Z-1787-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 17, 2020
- Termination Date
- October 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9137
Product Description
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason for Recall
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Code Information
Lot Numbers: V18031235 V18050229 V18050230 V18050231 V18050232 V18050233 V19027860 V19028470 V19018929