Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 1,588 Temperature Sensor 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 where the defective sensor could lead to inaccurate temperature readings, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Degania Silicone, Ltd. is recalling 1,588 units of the Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI. These sterile, single-use, two-way silicone Foley catheters feature a thermistor embedded in the third lumen and are intended for the drainage and collection of urine from the urinary bladder while simultaneously monitoring 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 show a lower body temperature than the actual body temperature of the patient.
The affected products 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 V17002337, V17003078, V17016095, and V17020364. Healthcare facilities and consumers should stop using these devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI 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 and
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 1,588
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)
- V17002337
- V17003078
- V17016095
- V17020364
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
- 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
- HighDegania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26