Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling Foley 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 the hazard involves a risk of harm (incorrect temperature monitoring) where specific injury or illness has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Degania Silicone, Ltd. is recalling 5,000 units of the Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP. 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 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 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 S17006052 and S17006060. Healthcare facilities and consumers should check their inventory for these specific catalogue numbers and lot codes and discontinue use of the affected devices.
The recalled product
- Product
- Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP 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 blad
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 5,000
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)
- S17006052
- S17006060
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 · defective sensor
See all →- ModerateLeica Biosystems Recalls Three Aperio CS2 CE IVD Scanners
FDA (Devices) · 2019-10-16
- HighDegania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26