Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 2,784 Thermistor 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 the hazard 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 2,784 units of Thermistor Foley catheters, Catalogue Number 102201101863MD. The affected products are nonsterile, single-use, two-way silicone Foley catheters with a thermistor embedded in the third lumen, intended for the drainage 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 display 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 specific lot codes associated with this recall are V17011921, V17026466, V17026467, and V17026862. Healthcare facilities and consumers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD 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 — Foley Catheter
- Affected units
- 2,784
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 (4)
- V17011921
- V17026466
- V17026467
- V17026862
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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