Covidien recalls specific models of Foley trays due to temperature sensor issues that could lead to incorrect patient temperature readings and improper treatment.
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 Foley trays that have a temperature sensor which may not measure body temperature accurately. This could lead to incorrect diagnoses and inadequate treatment of patients. The recall affects specific lot numbers and models.
The temperature sensor in the Foley tray may not function within the required tolerance of +/- 0.2°C. This could result in inaccurate patient body temperature measurements, potentially leading to incorrect diagnoses and insufficient treatment.
Healthcare professionals using the recalled Foley trays for urinary drainage and temperature monitoring. Patients receiving care with these devices may be at risk of incorrect temperature readings.
Check the product code on the tray, which should be P4P16XTSD. Look for lot numbers: 1828206564, 1828813264, 1829618264, 1829618364, 1831001964, 1906506564, 1907134164, 1909308864, 1919705064, 1921106664, 2000723764, 2003520164, 2005617664.
Look for the product code P4P16XTSD on the Foley tray.
Confirm the lot numbers match the listed numbers: 1828206564, 1828813264, 1829618264, 1829618364, 1831001964, 1906506564, 1907134164, 1909308864, 1919705064, 1921106664, 2000723764, 2003520164, 2005617664.
The temperature sensor may not measure body temperature within the required tolerance of +/- 0.2°C, which could lead to incorrect diagnoses and insufficient treatment.
Check the product code and lot numbers to see if it's affected. If it is, contact the manufacturer for further instructions.
The recall is due to potential incorrect temperature readings, which could lead to improper treatment. However, the remedy is not specified in the record.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1992-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1992-2020 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.
