Degania Foley Catheters Recalled Due to Defective Temperature Sensors
Degania Silicone is recalling Foley catheters with temperature sensors because defective units 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 risk-of-harm medical device where the hazard is a potential for inaccurate temperature readings, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Degania Silicone, Ltd. is recalling 92,150 units of the Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY. This sterile, single-use, two-way silicone catheter is 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, a defective catheter will show a lower body temperature than the actual body temperature of a 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 recall covers specific lot codes listed in the agency's records. Users should stop using the affected catheters and contact the manufacturer for further instructions.
The recalled product
- Product
- Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY 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 u
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 92,150
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 (20)
- S17002091
- S17002440
- S17001607
- S17002441
- S17002558
- S17002559
- S17002561
- S17002562
- S17002563
- S17002681
- S17003391
- S17004379
- S17002560
- S17002682
- S17003456
- S17003219
- S17003301
- S17003302
- S17004772
- S17004376
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.
See all 32 products in this recall →Related recalls
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Same hazard · inaccurate temperature reading
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- HighDegania Foley Temperature Sensor Catheters Recalled for Defective Sensors
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