Degania Silicone recalls temperature sensing catheters 16FR with possible defective sensors that may show lower body temperature than actual. Affected units sold with catalogue number 102201101663NU.
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. This could lead to incorrect medical decisions during surgery or recovery.
The catheters contain defective temperature sensors that may display a lower body temperature than the actual temperature. This could cause medical staff to make incorrect decisions about a patient's condition during critical procedures.
Healthcare professionals using these catheters during surgery or post-surgical care are most at risk. Patients receiving this type of catheter for temperature monitoring are also affected.
Check for the catalogue number 102201101663NU on the catheter packaging. These are sterile, single-use silicone catheters with a thermistor embedded in the third lumen.
Inspect the catheter for any visible damage or unusual temperature readings during use.
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 or action steps for affected users.
The recall states the catheters may show incorrect temperature readings, but does not specify a risk of serious injury.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2785-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2785-2018 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.
