Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.
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, fitting the rubric criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Degania Medical Devices Pvt. Ltd. is recalling specific lots of Temperature Sensing 100% Silicone Foley Catheters. The recall involves 34,785 units distributed worldwide, including the United States and Mexico.
The recall was initiated because inadequate incoming inspection practices were utilized on the thermistor sensors used in the production of the specified lots. These sensors are designed to measure temperature while draining the urinary bladder.
Affected lot numbers include V18013621, V18014635, V18025989, V18029252, V18032217, V18031184, V19006387, V18049356, V18049355, and V19008749. Healthcare providers and patients should check their inventory and discontinue use of these specific lots.
The recalled product
- Product
- 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.
- Manufacturer
- Degania Medical Devices Pvt. Ltd.
- Category
- Medical Device — Foley Catheter
- Affected units
- 34,785
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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