Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 500 temperature-sensing Foley 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 clinical monitoring (underestimating body temperature), representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Degania Silicone, Ltd. is recalling 500 units of Temperature Sensing 100% Silicone Foley Catheters, sterile, Catalogue Number 102201101480MD. 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 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 lot code is S17002603. Users should stop using the affected catheters and contact the manufacturer for further instructions.
The recalled product
- Product
- Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD 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 fr
- Manufacturer
- Degania Silicone, Ltd.
- Affected units
- 500
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)
- S17002603
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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