Device product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Z-1788-2020
Product summary
- Event
- Event 85327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67499
- Official record key
device-enforcement:Z-1788-2020
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: V18024145 V18024144 V18027064 V18026042 V18026043 V18026045 V18029205 V18029206 V18037913 V18049310 V19007111 V19007110 V19008666 V19008664 V19009594 V19013277 V19027814 V19027863 V19027865
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.