Degania Silicone recalls 10FR temperature sensor Foley catheters with defective thermistors 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 sterile, single-use Foley catheters with temperature sensors that may show lower body temperatures than actual. This could lead to inaccurate monitoring during surgery or recovery, potentially affecting patient care.
The catheters contain defective thermistors that may register lower body temperatures than the actual temperature. This could cause inaccurate monitoring of a patient's core temperature during critical medical procedures or recovery, potentially leading to improper treatment decisions.
Surgical patients receiving this catheter for temperature monitoring during surgery or post-surgical recovery are most at risk. Healthcare providers using this specific product for temperature measurement are affected.
Check for the catalogue number 102205101080AB on the catheter packaging. This is a sterile, single-use, two-way silicone Foley catheter with a thermistor embedded in the third lumen.
Look for the catalogue number 102205101080AB 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 102205101080AB to confirm if it is affected.
The recall indicates a potential issue with temperature readings, but the catheter is still considered safe for use if the temperature reading is verified by other means.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2756-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2756-2018 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.
