Degania Silicone recalls 18FR temperature sensor Foley catheters (Catalogue 102205101880AB) due to suspected defective sensors causing inaccurate body temperature readings during surgery or post-op 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 sterile, single-use temperature sensor Foley catheters that may show lower body temperature readings than actual patient temperatures. This could lead to improper temperature monitoring during surgery or recovery, potentially affecting patient care.
The catheters contain a suspected defective temperature sensor that may display a lower body temperature than the actual patient temperature. This could result in inaccurate temperature monitoring during critical medical procedures, potentially leading to improper patient care decisions.
Healthcare professionals using these catheters during surgery or post-surgical care are most at risk. Patients receiving this specific catheter type for temperature monitoring during medical procedures may be affected.
Check for the product name 'Temperature sensor Foley catheter 18FR' and catalogue number 102205101880AB. These are sterile, single-use catheters with a thermistor embedded in the third lumen.
Verify the product name and catalogue number to confirm if your catheter is affected.
The catheters are suspected to contain defective sensors that may show lower body temperature than the actual patient temperature during use.
The official recall notice does not specify a remedy or action steps for affected users.
The recall indicates a suspected defect that could cause inaccurate temperature readings, so it is not recommended for use until the manufacturer provides a remedy.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2754-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2754-2018 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.