Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
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, and the hazard involves a risk of harm (incorrect temperature monitoring) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Degania Silicone, Ltd. is recalling 250 units of the Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP. The product is a sterile, single-use, two-way silicone Foley catheter 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 show a lower body temperature than the actual body temperature of the patient.
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 code for the recalled units is S17006051. Users should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP 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 blad
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 250
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)
- S17006051
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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