FDA Enforcement
Class II
Terminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Recall: Z-1785-2020
·
Reported April 29, 2020
Enforcement
- Recall Number
- Z-1785-2020
- 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 102202101663DO - 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: V18013621 V18014635 V18025989 V18029252 V18032217 V18031184 V19006387 V18049356 V18049355 V19008749
Distribution
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Quantity
34785