Degania Silicone recalls 400TM 8FR catheters with temperature sensors that may show lower body temperature than actual. This could lead to inaccurate monitoring during surgery or post-surgery care.
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 because they may show lower body temperatures than actual. This could cause inaccurate monitoring of a patient's core temperature during surgery or recovery, potentially leading to complications.
The catheters have defective temperature sensors that may display a lower body temperature than the actual temperature. This could lead to incorrect monitoring of a patient's core temperature during surgery or after surgery, potentially causing complications if the temperature is misinterpreted.
Healthcare professionals using these catheters during surgery or post-surgical care are most at risk. Patients receiving this type of catheter for temperature monitoring are also affected.
Check for the product catalog number 102201100880TY on the catheter packaging. These catheters are sterile, single-use items with a thermistor embedded in the third lumen.
Look for the catalog number 102201100880TY on the catheter packaging to confirm if it is recalled.
The catheters may show lower body temperature than actual, which could lead to inaccurate monitoring during surgery or post-surgical care.
Check the product catalog number 102201100880TY on the packaging to see if it is recalled. If it is, contact Degania Silicone for further instructions.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2763-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2763-2018 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.
