Degania Silicone recalls temperature sensor catheters that may show inaccurate low body temperatures during surgery, risking patient safety. Affected units have specific catalogue numbers and were sold for medical use.
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 sensor catheters that may show lower body temperatures than actual patient temperatures during surgery. This could lead to incorrect medical decisions if the catheter is used.
The catheters contain defective temperature sensors that may register lower body temperatures than actual patient temperatures. This could cause medical staff to misinterpret the patient's condition during surgery or recovery.
Healthcare professionals using the catheters for surgical temperature monitoring are most at risk. Patients undergoing surgery with this specific catheter model may be affected.
Check for catalogue number 102201101463BI on the catheter packaging. The product is a sterile, single-use silicone catheter with a thermistor embedded in the third lumen.
Look for the catalogue number 102201101463BI on the catheter packaging or label.
The catheters are suspected to contain defective sensors that may show lower body temperatures than actual patient temperatures during surgery.
The recall record does not specify a remedy, so contact Degania Silicone directly for guidance.
Yes, the affected model has catalogue number 102201101463BI and was sold for medical use during the specified production periods.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2760-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2760-2018 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.
