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 practices were 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, placing it in the 'High' severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Degania Medical Devices Pvt. Ltd. is recalling 2,500 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102201100880MD. These are 3-lumen silicone catheters designed to measure temperature while draining the urinary bladder. The affected lots are S18013318, S18010936, S19006220, S19006221, S19006222, and S19006349.
The recall was initiated because inadequate incoming inspection practices were utilized on the thermistor sensors used in the production of these specific lots. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide distribution in the United States (specifically noting the state of Illinois) and in Mexico. Users of these medical devices should contact the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- 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.
- Manufacturer
- Degania Medical Devices Pvt. Ltd.
- Hazard
- Affected units
- 2,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: S18013318 S18010936 S19006220 S19006221 S19006222 S19006349
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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