Degania Silicone recalls 400TM 18FR catheters with temperature sensors that may show lower body temperature than actual. This could lead to inaccurate temperature monitoring during surgery or post-surgery care. 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 certain Foley catheters with temperature sensors because they may show lower body temperature than actual. This could lead to incorrect temperature readings 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 monitoring of a patient's core temperature during surgery or recovery, potentially causing complications if the temperature is misinterpreted.
Healthcare professionals using the catheters for surgical or post-surgical patient monitoring are most at risk. Patients undergoing procedures requiring temperature monitoring may also be affected.
Check for the catalogue number 102201101880TY 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 102201101880TY on the catheter packaging or label.
Reach out to Degania Silicone for further assistance or to confirm if your catheter is affected.
The catheters are suspected to contain defective sensors that may show lower body temperature than actual, which could lead to inaccurate temperature monitoring during surgery or recovery.
Check the catalogue number on the packaging. If you have the affected model, contact Degania Silicone for further instructions.
The recall states the catheters may show lower body temperature than actual, but it does not specify a risk of serious injury. The hazard is related to inaccurate temperature readings, not direct 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-2767-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2767-2018 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.
