Degania Silicone recalls temperature sensing catheters with defective sensors that may show lower body temperature than actual patient temperature during surgery or post-op care. Affected models include 14FR with Catalogue Number 102203101463DO.
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 temperature sensing catheters that may show lower body temperature readings than actual patient temperatures. This could lead to incorrect temperature monitoring during surgery or recovery, potentially affecting patient care.
The catheters contain defective temperature sensors that may display lower body temperatures than the actual patient temperature. This could result in inaccurate monitoring during critical medical procedures or recovery periods, potentially leading to improper treatment decisions.
Healthcare professionals using the catheters during surgery or post-surgical care are most at risk. Patients receiving this type of catheter monitoring are also affected.
Check for the product name 'Temperature sensing catheter 14FR' with Catalogue Number 102203101463DO. The catheters are sterile, single-use, two-way silicone Foley catheters with a thermistor embedded in the third lumen.
Verify the Catalogue Number 102203101463DO on the catheter packaging or label.
The catheters are suspected to contain defective sensors that may show lower body temperature than the actual patient temperature during surgery or post-surgical care.
The recall record does not specify a remedy or action steps for affected users.
Yes, the affected model is Temperature sensing catheter 14FR with Catalogue Number 102203101463DO.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2781-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2781-2018 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.