Recall Z-1789-2020— Degania Medical Devices Pvt. Ltd.
Class II · Terminated
Class II FDA medical device recall by Degania Medical Devices Pvt. Ltd., initiated 2020-03-17, terminated 2024-10-25. It names one FDA 510(k) clearance: K063442. Product: Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - 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..
- Recalling firm
- Degania Medical Devices Pvt. Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-17
- Terminated
- 2024-10-25
- Firm location
- Gurgaon, N/A, India
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.