Degania Temperature Sensing Foley Catheters Recalled for Sensor 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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is related to inspection practices rather than a confirmed high-risk pathogen or structural defect causing harm.
Plain-English summary
Degania Medical Devices Pvt. Ltd. is recalling 16,393 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102201101463MD. The recall covers specific lots distributed worldwide, including nationwide in the United States and in 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 the catheter drains the urinary bladder.
Healthcare facilities and consumers who have these specific lots of catheters should stop using them and contact Degania Medical Devices for further instructions. The affected lot numbers are V18022033, V18025110, V18025111, V18029225, V18029226, V19024273, V19013327, V19025875, V19016720, and V19025874.
The recalled product
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - 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
- 16,393
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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