Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
Degania Silicone is recalling 16,133 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 medical device that may provide inaccurate vital sign data (temperature) without reported injuries, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Degania Silicone, Ltd. is recalling 16,133 units of the Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI. This sterile, single-use, two-way silicone Foley catheter features a thermistor embedded in the third lumen and is intended for the drainage and collection of urine from the urinary bladder while simultaneously monitoring 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, a defective catheter 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. Affected lot codes include V17018057, V17022043, V17023777, V17018058, V17012115, V17002305, V17002306, and V17002308. Healthcare facilities and consumers should stop using these devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI 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 bladder an
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 16,133
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 (8)
- V17018057
- V17022043
- V17023777
- V17018058
- V17012115
- V17002305
- V17002306
- V17002308
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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