Degania recalls 14FR Foley catheters with temperature sensors due to suspected defective sensors that may show lower body temperature than actual. This could lead to inaccurate monitoring during surgery or post-surgery care. 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 is recalling a specific type of sterile, single-use Foley catheter with a temperature sensor because it may show lower body temperature than actual. This could lead to incorrect temperature readings during surgery or recovery, potentially affecting patient care.
The catheter's temperature sensor may give false low readings compared to actual body temperature. This could lead to inaccurate monitoring of a patient's core temperature during critical medical procedures or recovery, potentially causing complications if the temperature is misinterpreted.
Healthcare professionals using the catheter during surgery or post-surgical care are most at risk. Patients receiving this catheter for urinary drainage and temperature monitoring are affected.
Check for the product name 'Foley Catheter with temperature sensor 400TM 14FR' and catalogue number 102201101480TY. The catheter is sterile, single-use, and has a thermistor embedded in the third lumen.
Verify the product name and catalogue number to confirm if your catheter is affected.
Reach out to Degania Silicone, Ltd. for further assistance or to confirm if your catheter is part of the recall.
The catheters are suspected to contain defective sensors that may show lower body temperature than actual, which could lead to inaccurate monitoring during surgery or post-surgical care.
Check the product name and catalogue number to confirm if it's affected. Contact Degania Silicone, Ltd. for further instructions.
The recall states the catheters may show lower body temperature than actual, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Degania to request your refund or repair — edit it as you like.
Subject: Recall Z-2765-2018 — Degania Degania Hello, I own a Degania that is covered by recall Z-2765-2018 from Degania. 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.
