Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
Degania Medical Devices is recalling 1,929 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, placing this 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 1,929 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102201101063MD. The affected product is a 3-lumen silicone catheter with a sensor designed to measure temperature while draining the urinary bladder. The specific lot number for this recall is V18022032.
The recall was initiated because inadequate incoming inspection practices were utilized on the thermistor sensors used in the production of the specified lots. This defect could potentially affect the accuracy of the temperature measurements provided by the device.
The affected units 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 stop using the affected catheters and contact Degania Medical Devices for further instructions or a replacement.
The recalled product
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - 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
- 1,929
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: V18022032
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.
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- HighDegania Temperature Sensing Foley Catheters Recalled for Sensor Inspection Failures
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- 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
Same hazard · inadequate inspection
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