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

March 17, 2020

Class II

Product summary

Firm: Degania Medical Devices Pvt. Ltd.
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
reason.no_named_rule · v1.0.0

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.