Device product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Z-1783-2020
Product summary
- Event
- Event 85327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52566
- Official record key
device-enforcement:Z-1783-2020
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: V18007422 V18010291 V18023106 V18023107 V18023108 V18023109 V18025115 V18025117 V18025118 V18025119 V18026073 V18037032 V18026072 V18035228 V18035229 V18036131 V18037031 V18037033 V18037938 V19001678 V19001679 V19002478 V19002479 V19002480 V19013333 V19025876 V19026564 V19027234 V19027235 V19016726
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.