Foley Catheter with Temperature Sensor Recalled for Defective Sensors
Degania Silicone is recalling 12,532 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential for inaccurate temperature readings without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Degania Silicone, Ltd. is recalling 12,532 units of the Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY. This sterile, single-use, two-way silicone catheter is intended for the drainage and collection of urine from the urinary bladder and for 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, these 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 recall covers specific lot codes, including S17002333, S17002452, S17002892, S17003578, S17005045, S17003306, S17005046, S17007065, S17005298, S17000279, S17000280, S17000837, S17007171, S18001346, and S17000333.
The recalled product
- Product
- Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY 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…
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 12,532
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 (15)
- S17002333
- S17002452
- S17002892
- S17003578
- S17005045
- S17003306
- S17005046
- S17007065
- S17005298
- S17000279
- S17000280
- S17000837
- S17007171
- S18001346
- S17000333
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
- 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
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