Degania Silicone recalls sterile single-use temperature sensor catheters that may show inaccurate low body temperatures during surgery. Affected models include Catalogue Number 102201101863BI. Consumers should contact the manufacturer for details.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Degania Silicone is recalling sterile, single-use temperature sensor catheters that may show lower body temperatures than actual patient temperatures. This could lead to incorrect temperature readings during surgery or post-surgical care, potentially affecting patient safety.
Defective sensors in the catheters may display lower body temperatures than the actual patient temperature. This could lead to incorrect temperature readings during surgery or post-surgical care, potentially causing unsafe medical decisions.
Healthcare professionals using the catheters for surgical temperature monitoring and patients undergoing procedures where temperature monitoring is critical are most at risk. The recall affects specific models sold for medical use.
Check for the Catalogue Number 102201101863BI on the catheter packaging. The product is a sterile, single-use silicone Foley catheter with a thermistor embedded in the third lumen, intended for surgical temperature monitoring.
Look for the Catalogue Number 102201101863BI on the catheter packaging or label.
Defective sensors may show lower body temperatures than actual patient temperatures, which could lead to incorrect temperature readings during surgery or post-surgical care.
Check for the Catalogue Number 102201101863BI on the catheter packaging or label. The product is a sterile, single-use silicone Foley catheter with a thermistor embedded in the third lumen.
The recall record does not specify a remedy, so contact Degania Silicone directly for instructions.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2762-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2762-2018 from Degania Silicone. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
