Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 2,461 temperature sensing Foley 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Degania Silicone, Ltd. is recalling 2,461 units of Temperature sensing catheter 18FR, Catalogue Number 102203101863DO. The affected products are sterile, single-use, two-way silicone Foley catheters with a thermistor embedded in the third lumen, intended for urine drainage 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 agency classification for this recall is Class II.
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 V17015592 and V17016065. Healthcare providers and facilities should stop using these specific catheters and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Temperature sensing catheter 18FR, Catalogue Number 102203101863DO 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 a
- Manufacturer
- Degania Silicone, Ltd.
- Affected units
- 2,461
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)
- V17015592
- V17016065
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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