Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
Degania Medical Devices is recalling 9,137 temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Degania Medical Devices Pvt. Ltd. is recalling 9,137 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102203101463DO. The recall is due to inadequate incoming inspection practices utilized on the thermistor sensors used in the production of the specified lots.
The affected lots are V18031235, V18050229, V18050230, V18050231, V18050232, V18050233, V19027860, V19028470, and V19018929. The products were distributed worldwide, including nationwide in the United States (specifically noting the state of Illinois) and in Mexico.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected catheters. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - 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
- Hazard
- Affected units
- 9,137
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
- HighDegania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
FDA (Devices) · 2020-04-29
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