Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 11,488 temperature sensor Foley catheters because defective sensors may display lower body temperatures than actual.
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 no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Degania Silicone, Ltd. is recalling 11,488 units of Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB. 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 is being conducted because the catheters are suspected to contain defective sensors. If used, the defective catheters will 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 involved are S17000347, S17000747, S17000805, S17001070, S17005572, S17006024, and S17006420. Healthcare providers and facilities should stop using these devices and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB 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 bladd
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Foley Catheter
- Affected units
- 11,488
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)
- S17000347
- S17000747
- S17000805
- S17001070
- S17005572
- S17006024
- S17006420
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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