Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
Degania Medical Devices is recalling 700 temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 hazard involves a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Degania Medical Devices Pvt. Ltd. is recalling 700 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102201101080MD. The recall affects Lot Number S18012796. These devices are 3-lumen silicone catheters designed to measure temperature while draining the urinary bladder.
The recall was initiated because inadequate incoming inspection practices were utilized on the thermistor sensors used in the production of the specified lots. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide distribution in the United States and in Mexico. The source text does not specify specific states or facilities within the US, though the structured data mentions Illinois. Consumers and healthcare providers should stop using the affected catheters and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - 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.
- Affected units
- 700
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: S18012796
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
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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
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