Covidien recalls 16FR silicone coated foley catheters with temperature sensors due to potential inaccurate temperature readings, which could lead to incorrect diagnoses and inadequate treatment. Affected units were sold with specific product codes and lot numbers.
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 includes a temperature sensor. The device may not measure body temperature accurately, which could lead to wrong diagnoses or improper treatment. This is a serious issue for patients needing precise temperature monitoring.
The catheter's temperature sensor may not read body temperature within the required tolerance of +/- 0.2°C. This inaccuracy could cause healthcare providers to misdiagnose infections or other conditions, leading to inadequate treatment.
Patients using this catheter for urinary drainage and temperature monitoring are affected. Healthcare providers who prescribe or use this product are most at risk of incorrect medical decisions.
Check for the product code 50516ICT and lot number 1909500464 on the catheter packaging. This specific model was sold for urinary drainage with temperature monitoring.
Look for the product code 50516ICT and lot number 1909500464 on the catheter packaging.
The temperature sensor may not measure body temperature within the required tolerance of +/- 0.2°C, which could lead to incorrect diagnoses and inadequate treatment.
Check the product code and lot number on the packaging. If you have the specific model, contact your healthcare provider for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1985-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1985-2020 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.
