Degania Silicone recalls 14FR Foley Temperature Sensor Catheters with defective sensors that may show lower body temperature than actual. This sterile single-use catheter is for surgical temperature monitoring. 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 14FR Foley Temperature Sensor Catheters that may show lower body temperature than actual. This defect could lead to incorrect temperature readings during surgery or post-surgery care, potentially affecting patient monitoring.
The catheters contain defective temperature sensors that may display a lower body temperature reading than the actual temperature. This could lead to inaccurate monitoring during critical medical procedures or recovery periods, potentially causing mismanagement of patient temperature.
Healthcare professionals using the catheters for surgical temperature monitoring during procedures or post-surgical care are most at risk. Patients receiving this monitoring are affected if the catheter is used incorrectly.
Check for the catalogue number 102201101480JP on the catheter packaging. These are sterile, single-use catheters with a thermistor embedded in the third lumen for temperature monitoring during surgery or post-surgical care.
Look for the catalogue number 102201101480JP 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 actual, which could lead to inaccurate temperature monitoring during surgery or post-surgical care.
Check the product details for the catalogue number 102201101480JP. If you have the affected model, stop using it and contact the manufacturer for further instructions.
The recall record does not mention any remedy or fix 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-2771-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2771-2018 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.
