Covidien recalls specific silicone foley catheters with temperature sensors due to potential inaccurate temperature readings, which could lead to incorrect diagnoses and inadequate treatment. Product code 50516T, lot numbers 1908700664 and 1918351164.
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 certain silicone foley catheters with temperature sensors because they may not measure body temperature accurately. This could lead to incorrect diagnoses and insufficient treatment for patients. Affected products have specific product codes and lot numbers.
The catheters may fail to meet the required temperature sensing tolerance of +/- 0.2°C. This could result in inaccurate patient temperature readings, leading to incorrect diagnoses and inadequate treatment.
Healthcare professionals and patients using the recalled catheters for urinary drainage and temperature monitoring. Those with medical conditions requiring precise temperature readings are at higher risk.
Check for product code 50516T on the catheter packaging. Lot numbers 1908700664 and 1918351164 are associated with this recall. The catheters are used for urinary drainage and temperature monitoring.
Verify the product code on the catheter packaging is 50516T.
Consult with your healthcare provider about the catheter's safety and whether it needs replacement.
The catheters may not measure body temperature accurately, which could lead to incorrect diagnoses and inadequate treatment.
Product code 50516T.
Lot numbers 1908700664 and 1918351164.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1986-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1986-2020 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.
