Z-1786-2020 Class II Terminated
FDA device recall Z-1786-2020 was initiated by Degania Medical Devices Pvt. Ltd. on March 17, 2020 and is designated Class II. Reason for recall: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. The recall status is terminated (terminated October 25, 2024). Affected quantity: 2698.
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
- 2698
Product Description
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - 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: V19012401 V19012403