Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection was used on the thermistor sensors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Degania Medical Devices Pvt. Ltd. is recalling 67,499 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102203101663DO. These medical devices are 3-lumen silicone catheters designed to drain the urinary bladder while measuring temperature.
The recall was initiated because inadequate incoming inspection practices were utilized on the thermistor sensors used in the production of the specified lots. The affected products were distributed worldwide, including nationwide in the United States (specifically mentioning Illinois) and in Mexico. The recall covers 19 specific lot numbers, including V18024145, V18024144, and V18027064.
Healthcare facilities and distributors should check their inventory for the affected part number and lot numbers. Users should stop using the affected catheters and contact the recalling firm for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- 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.
- Manufacturer
- Degania Medical Devices Pvt. Ltd.
- Affected units
- 67,499
Distribution
Part of a larger recall action
This product is one of 11 recalled by Degania Medical Devices Pvt. Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Degania Medical Devices Pvt. Ltd.
See all →- ModerateDegania Temperature Sensing Foley Catheters Recalled for Inspection Failures
FDA (Devices) · 2020-04-29
- HighDegania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
FDA (Devices) · 2020-04-29
- HighDegania Temperature Sensing Foley Catheters Recalled for Sensor Inspection Failures
FDA (Devices) · 2020-04-29
- SevereDegania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
FDA (Devices) · 2020-04-29
- ModerateDegania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
FDA (Devices) · 2020-04-29
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