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 actual.
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 involves a medical device with a defect that could lead to inaccurate temperature monitoring, posing a risk of harm to patients, but no injuries or illnesses have been reported.
Plain-English summary
Degania Silicone, Ltd. is recalling 250 units of the Foley Temperature Sensor Catheter 10FR (Catalogue Number 102201101080JP). 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 suspicion that the catheters 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 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 code for the recalled units is S17000804. Users should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP 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)
- S17000804
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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