Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 330 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 involves a medical device with a defect that could lead to incorrect clinical readings (underestimating body temperature), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Degania Silicone, Ltd. is recalling 330 units of Thermistor Foley catheters, nonsterile, Catalogue Number 102201100863MD. These are sterile, single-use, two-way silicone Foley catheters 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 defect in the sensors. If used, the defective catheters are suspected to 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. The specific code for the affected units is V170160900. Consumers and healthcare providers should stop using these catheters and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD 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
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Foley Catheter
- Affected units
- 330
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)
- V17016090
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
Same manufacturer · Degania Silicone, Ltd.
See all →- ModerateMedline Thermistor Foley Catheter Recalled for Temperature Deviation
FDA (Devices) · 2020-01-22
- SevereDegania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
FDA (Devices) · 2019-08-21
- SevereCardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
FDA (Devices) · 2019-08-21
- SevereSmith & Nephew Wound Drain Recall Due to Breakage Risk
FDA (Devices) · 2019-08-21
- SevereDegania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
FDA (Devices) · 2019-08-21
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