Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 34,627 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Degania Silicone, Ltd. is recalling 34,627 units of the Temperature sensing catheter 16FR, Catalogue Number 102203101663DO. 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 was initiated because the catheters are suspected to contain defective sensors. If used, these defective catheters may display a lower body temperature than the patient's actual body temperature. The affected units were distributed worldwide, including nationwide in the United States (Illinois, North Carolina, and New York) and in Belgium, Israel, Japan, and Mexico. The specific lot codes associated with this recall are V17005873, V17009855, V17012488, V17013273, V17016034, V17002138, and V17000832.
Healthcare facilities and consumers should stop using the affected catheters and contact Degania Silicone, Ltd. for further instructions or a return.
The recalled product
- Product
- Temperature sensing catheter 16FR, Catalogue Number 102203101663DO 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…
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Catheters
- Affected units
- 34,627
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 (7)
- V17005873
- V17009855
- V17012488
- V17013273
- V17016034
- V17002138
- V17000832
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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FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
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