Z-1785-2020 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
- 34785
Product Description
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - 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: V18013621 V18014635 V18025989 V18029252 V18032217 V18031184 V19006387 V18049356 V18049355 V19008749