Degania Silicone Recalls Foley Catheters with Defective Temperature Sensors
Degania Silicone is recalling 89,122 Foley catheters with temperature sensors 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. The hazard involves a risk of harm (inaccurate temperature monitoring) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Degania Silicone, Ltd. is recalling 89,122 units of the Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY. 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 will show 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. Users should stop using the affected catheters and contact the manufacturer for further instructions.
The recalled product
- Product
- Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY 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 u
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 89,122
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 (20)
- S17001226
- S17002082
- S17002550
- S17002784
- S17002883
- S17002884
- S17005004
- S17003784
- S17003785
- S17002982
- S17002983
- S17003916
- S17003917
- S17004351
- S17005957
- S17006689
- S17007029
- S17004746
- S17004877
- S17005956
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.
See all 32 products in this recall →Related recalls
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Same hazard · inaccurate temperature reading
See all →- HighDover Foley Catheters Recalled for Temperature Sensor Inaccuracy
FDA (Devices) · 2020-05-20
- HighDegania Foley Temperature Sensor Catheters Recalled for Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- ModerateFoley Catheter with Temperature Sensor Recalled for Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26