Device product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Z-1789-2020
Product summary
- Event
- Event 85327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1578
- Official record key
device-enforcement:Z-1789-2020
Official wording
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Code information: Lot Numbers: V19008709 V19016709
Distribution pattern: Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Derived failure modes
-
Unknown
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.