Degania Silicone recalls 12FR Foley Temperature Sensor Catheters with defective thermistors that may show lower body temperature than actual patient temperature 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 12FR 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.
The catheters contain defective temperature sensors that may display a lower body temperature than the actual temperature. This could lead to inaccurate 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 product name 'Foley Temperature Sensor Catheter 12FR' and catalogue number 102201101280JP. These catheters were sold as sterile, single-use items for surgical temperature monitoring.
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 actual patient temperature during surgery or post-surgical care.
The recall record does not specify a remedy, so check with the manufacturer for guidance.
The recall indicates potential issues with temperature readings, so it's recommended to check with the manufacturer before use.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2770-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2770-2018 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.