Covidien recalls 14FR 5CC2W silicone catheters with temperature sensors due to potential inaccurate temperature readings, which could lead to incorrect diagnoses and 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 measures temperature. The device might not read body temperature correctly, which could cause wrong diagnoses and inadequate treatment. This is serious because medical errors can have serious consequences.
The catheter's temperature sensor may not stay within a tight calibration range (±0.2°C), leading to inaccurate readings. If the device shows a temperature that doesn't match the patient's actual body temperature, healthcare providers might misdiagnose infections or other conditions and provide incorrect treatments.
Healthcare professionals and patients using the recalled catheter for urinary drainage and temperature monitoring. Those with medical conditions requiring precise temperature readings are at higher risk.
Check for the product code 50514T on the catheter packaging. The lot number 1910100464 is associated with this recall. This catheter is used for urinary drainage and temperature monitoring only.
Look for the product code 50514T and lot number 1910100464 on the catheter packaging.
The recall indicates the temperature sensor may not read temperatures accurately, which could lead to incorrect diagnoses and treatments. It is not safe to use as intended without verification.
Check for the product code 50514T and lot number 1910100464 on the catheter packaging. This catheter is used for urinary drainage and temperature monitoring only.
The recall does not specify a remedy, so contact the manufacturer or healthcare provider for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1984-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1984-2020 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.
