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. The hazard involves a medical device providing inaccurate temperature readings, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Degania Silicone, Ltd. is recalling 250 units of the Foley Temperature Sensor Catheter 8FR (Catalogue Number 102201100880JP). 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 due to a defect in the sensors. If used, the defective catheters are suspected to 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 source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units.
The recalled product
- Product
- Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP 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 — Catheters
- Hazard
- 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)
- S17000350
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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