Degania Silicone recalls 10FR Foley Temperature Sensor Catheters with defective thermistors that may show lower body temperature than actual patient temperature during surgery or post-op 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 Silicone is recalling sterile Foley Temperature Sensor Catheters that may show lower body temperature than actual patient temperature. This could lead to inaccurate temperature monitoring during surgery or recovery, potentially affecting patient care decisions.
The catheters contain defective temperature sensors that may display a lower body temperature than the actual temperature. This could lead to incorrect temperature readings during critical medical procedures, potentially causing improper patient care decisions.
Healthcare professionals using these catheters during surgery or post-surgical care are most at risk. Patients receiving this specific catheter for temperature monitoring during medical procedures may be affected.
Check for the catalogue number 1022011:1080JP on the catheter packaging. These are sterile, single-use catheters with a thermistor embedded in the third lumen, intended for urinary drainage and temperature monitoring during surgery or post-surgical periods.
Look for the catalogue number 102201101080JP 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 body temperature of a patient.
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.
The recall record states these catheters are sterile and single-use, but the defective sensors may cause inaccurate temperature readings during medical procedures.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2769-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2769-2018 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.
