Covidien recalls specific silicone-coated catheters with temperature sensors due to potential inaccurate temperature readings, which could lead to incorrect diagnoses and treatment. Affected units include model 5CCCC2W with product code 505:18ICT.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Covidien is recalling a specific type of urinary catheter that has a temperature sensor. If the sensor doesn't work correctly, it might give wrong temperature readings, which could lead to incorrect medical diagnoses and treatments.
The temperature sensor in these catheters may not measure body temperature accurately within the required tolerance of +/- 0.2°C. This could result in incorrect diagnoses and inadequate treatment if the temperature readings are not reliable.
Healthcare professionals and patients using the specific catheter model for urinary drainage and temperature monitoring. Those with the product code 50518ICT are most at risk.
Check for the model number 5CCCC2W and product code 50518ICT on the catheter packaging or label. The catheter is designed for urinary drainage and temperature monitoring under prescription.
Look for the model number 5CCCC2W and product code 50518ICT on the catheter packaging or label.
The temperature sensor may not measure body temperature accurately within the required tolerance of +/- 0.2°C, which could lead to incorrect diagnoses and insufficient treatment.
The recall record does not specify a remedy, so check with your healthcare provider for guidance.
The recall indicates a potential issue with temperature accuracy, but the catheter is still safe for use unless the temperature sensor fails.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1987-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1987-2020 from Covidien. 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.
