Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 1,000 temperature sensing 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 involves a medical device with a defect that could lead to inaccurate clinical monitoring (incorrect temperature readings), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Degania Silicone, Ltd. is recalling 1,000 units of Temperature Sensing 100% Silicone Foley Catheters, sterile, Catalogue Number 102201100880MD. The affected units are identified by lot codes S17001781 and S17002824. These sterile, single-use catheters are intended for the drainage 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 products were distributed worldwide, including in the United States (Illinois, North Carolina, and New York) and in Belgium, Israel, Japan, and Mexico.
Healthcare facilities and consumers who have these specific lot codes should stop using the product and contact Degania Silicone, Ltd. for further instructions.
The recalled product
- Product
- Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD 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 fr
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Urological
- Hazard
- Affected units
- 1,000
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)
- S17001781
- S17002824
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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