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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Degania Medical Devices Pvt. Ltd. is recalling 2,698 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102202101863DO. The affected lots are V19012401 and V19012403. 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 these specific lots. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected products were distributed worldwide, including nationwide distribution in the United States (specifically mentioning the state of Illinois) and in Mexico. Users of these medical devices should contact the recalling firm for instructions on how to return or replace the affected units.
The recalled product
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - 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
- 2,698
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: V19012401 V19012403
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
- ModerateDegania 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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