Degania Silicone recalls temperature sensor catheters that may show inaccurate low body temperature readings during surgery, risking patient safety. Affected units have specific catalogue numbers and were sold for medical use.
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 temperature sensor catheters that may show lower body temperature than actual patient temperature. This could lead to incorrect medical decisions during surgery or post-surgery care.
Defective sensors in the catheters may show lower body temperature readings than the actual patient temperature. This could lead to incorrect medical decisions, such as administering unnecessary treatments or delaying critical care.
Healthcare professionals using the catheters for surgical temperature monitoring are most at risk. Patients undergoing surgery or post-surgical care with these catheters could be affected.
Check for the catalogue number 102201101663BI on the catheter packaging. The product is a sterile, single-use silicone Foley catheter with a thermistor embedded in the third lumen.
Look for the catalogue number 102201101663BI on the catheter packaging to confirm if it is affected.
The catheters are suspected to contain defective sensors that may show lower body temperature than the actual patient temperature, potentially leading to incorrect medical decisions.
The recall record does not specify a remedy, so check the catalogue number to confirm if it is affected and contact the manufacturer for further instructions.
Yes, the affected units have the catalogue number 102201101663BI and were sold with specific serial numbers listed in the product description.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2761-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2761-2018 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.
