Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 14,326 Thermistor Foley catheters because defective sensors may display inaccurate, lower body temperature readings.
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. The hazard involves a risk of harm (inaccurate temperature monitoring) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Degania Silicone, Ltd. is recalling 14,326 units of Thermistor Foley catheters, nonsterile, Catalogue Number 102201101663MD. The affected products are sterile, single-use, two-way silicone Foley catheters with a thermistor embedded in the third lumen, intended for the drainage and collection of urine from the urinary bladder and simultaneous monitoring of body core temperature during surgery or the post-surgical period.
The recall is being conducted because the catheters are suspected to contain defective sensors. If used, the defective catheters may display a lower body temperature than the patient's actual body temperature. The affected units were distributed worldwide, including in the United States (Illinois, North Carolina, and New York) and in Belgium, Israel, Japan, and Mexico.
The specific lot codes associated with this recall are V17012299, V17012518, V17012896, V17013267, V17013268, V17013272, V17023765, V17025022, V17025023, and V17026861. Healthcare facilities and consumers should stop using the affected catheters and contact the recalling firm for further instructions.
The recalled product
- Product
- Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladd
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Foley Catheter
- Affected units
- 14,326
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 (10)
- V17012299
- V17012518
- V17012896
- V17013267
- V17013268
- V17013272
- V17023765
- V17025022
- V17025023
- V17026861
Distribution
Part of a larger recall action
This product is one of 32 recalled by Degania Silicone, 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.
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