FDA Enforcement
Class II
Terminated
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.
Recall: Z-1788-2020
·
Reported April 29, 2020
Enforcement
- Recall Number
- Z-1788-2020
- Event ID
- 85327
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Degania Medical Devices Pvt. Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2020
- Initiation Date
- March 17, 2020
- Classification Date
- April 23, 2020
- Termination Date
- October 25, 2024
- Address
- Plot No 251, Imt Manesar, Gurgaon, N/A, N/A, India
Description
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.
Reason
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Code Info
Lot Numbers: V18024145 V18024144 V18027064 V18026042 V18026043 V18026045 V18029205 V18029206 V18037913 V18049310 V19007111 V19007110 V19008666 V19008664 V19009594 V19013277 V19027814 V19027863 V19027865
Distribution
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Quantity
67499