Degania Foley Catheters Recalled for Defective Temperature Sensors
Degania Silicone is recalling 47,520 Foley catheters with temperature sensors 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 medical device that may provide inaccurate physiological data (body temperature) during critical care, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Degania Silicone, Ltd. is recalling 47,520 units of the Foley Catheter with temperature sensor 400TM 12FR (Catalogue Number 102201101280TY). These are sterile, single-use, two-way silicone catheters 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 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. The specific lot codes affected are S17000808, S17000943, S17000946, S17002077, S17001347, S17002197, S17002979, S17003351, S17003439, S17003347, S17003350, S17004190, S17004479, S17004736, S17000809, S17000660, S17001348, S17001349, S17005948, and S17005949. Healthcare providers and facilities should stop using these devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY 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.
- Affected units
- 47,520
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)
- S17000808
- S17000943
- S17000946
- S17002077
- S17001347
- S17002197
- S17002979
- S17003351
- S17003439
- S17003347
- S17003350
- S17004190
- S17004479
- S17004736
- S17000809
- S17000660
- S17001348
- S17001349
- S17005948
- S17005949
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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