Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 1,025 Temperature Sensor Catheters because defective sensors may display lower body temperatures than actual patient 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 medical device that may provide inaccurate vital sign data (temperature), which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Degania Silicone, Ltd. is recalling 1,025 units of the Temperature Sensor Catheter 18FR (Catalogue Number 102201101863BI). 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 was initiated 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 a patient.
The affected units were distributed worldwide, including nationwide in the United States in the states of Illinois, North Carolina, and New York, as well as in Belgium, Israel, Japan, and Mexico. The specific lot codes associated with this recall are V17018059 and V17026475. Healthcare facilities and consumers should stop using these specific catheters and contact the recalling firm for further instructions.
The recalled product
- Product
- Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI 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 bladder an
- Manufacturer
- Degania Silicone, Ltd.
- Affected units
- 1,025
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 (2)
- V17018059
- V17026475
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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