FDA Enforcement
Class II
Terminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Recall: Z-1779-2020
·
Reported April 29, 2020
Enforcement
- Recall Number
- Z-1779-2020
- 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 102201100880MD - 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: S18013318 S18010936 S19006220 S19006221 S19006222 S19006349
Distribution
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Quantity
2500