Degania Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling 16,350 temperature sensor 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. The hazard involves a risk of harm (inaccurate temperature monitoring) for a medical device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Degania Silicone, Ltd. is recalling 16,350 units of the Temperature Sensor Catheter 14FR (Catalogue Number 102201101463BI). These sterile, single-use, two-way silicone Foley catheters feature a thermistor embedded in the third lumen and are intended for draining urine from the bladder while simultaneously monitoring 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 display a lower body temperature than the patient's actual body temperature.
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 involved are V17005889, V17010230, V17012903, V17011659, V17017036, V17019527, V17018055, V17026037, and V17026408. Healthcare facilities should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI 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
- Hazard
- Affected units
- 16,350
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 (9)
- V17005889
- V17010230
- V17012903
- V17011659
- V17017036
- V17019527
- V17018055
- V17026037
- V17026408
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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