Degania Silicone recalls 12FR Foley catheters with temperature sensors that may show lower body temperature than actual patient temperature. This could lead to inaccurate monitoring during surgery or post-surgery. Affected units have specific catalogue numbers.
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 certain Foley catheters with temperature sensors that may show lower body temperature than actual patient temperature. This could lead to inaccurate monitoring during surgery or post-surgical care, potentially affecting patient safety.
The catheters contain defective temperature sensors that may display a lower body temperature reading than the actual patient temperature. This could lead to incorrect temperature assessments during critical medical procedures, potentially causing complications if the patient's true temperature is not accurately monitored.
Healthcare professionals using the recalled catheters for surgical or post-surgical patient monitoring are most at risk. Patients undergoing procedures requiring temperature monitoring may also be affected.
Check for the catalogue number 102201101280TY on the catheter packaging. The product is a sterile, single-use silicone catheter with a thermistor embedded in the third lumen, intended for urinary drainage and temperature monitoring during surgery or post-surgery.
Verify the catalogue number 102201101280TY on the catheter packaging to confirm if it is affected.
The recalled model is the Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY.
The catheters may contain defective sensors that show lower body temperature than the actual patient temperature, which could lead to inaccurate monitoring during surgery or post-surgical care.
Check for the catalogue number 102201101280TY on the packaging. The product is a sterile, single-use silicone catheter with a thermistor embedded in the third lumen.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2764-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2764-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
