Degania Silicone Recalls Foley Catheters with Defective Temperature Sensors
Degania Silicone is recalling 4,332 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 and involves a medical device that may provide inaccurate vital sign data (temperature) during critical care, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Degania Silicone, Ltd. is recalling 4,332 units of the Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY. The affected products 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 being conducted 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 in the United States (Illinois, North Carolina, and New York) and in Belgium, Israel, Japan, and Mexico. The specific lot codes associated with this recall are S17002877, S17002878, S17003909, S17004477, S17005607, S17006814, and S17005115.
Healthcare facilities and consumers should stop using the affected catheters immediately and contact Degania Silicone, Ltd. for instructions on returning the products. This recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY 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 ur
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 4,332
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 (7)
- S17002877
- S17002878
- S17003909
- S17004477
- S17005607
- S17006814
- S17005115
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.
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