Covidien recalls specific models of urine meter foley trays that may not accurately measure body temperature, risking incorrect diagnoses and treatment. Affected units include certain lot numbers from 2004-2006.
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 specific models of urine meter foley trays that may not measure body temperature correctly. This could lead to incorrect diagnoses and inadequate treatment of patients. The recall affects medical devices used for urinary drainage and temperature monitoring.
The temperature sensors in these foley trays may not accurately measure body temperature within the required tolerance of +/- 0.2°C. This could result in incorrect diagnoses and insufficient treatment if the temperature readings are not precise.
Healthcare professionals and patients using the recalled foley trays for urinary drainage and temperature monitoring. Those with medical conditions requiring precise temperature monitoring are at higher risk.
Check for the product code P4P16TSD on the device. Look for lot numbers listed: 1826714264, 1908533364, 1909302964, 1909303064, 1910654864, 1911300664, 1916240464, 1921106564, 1922533864, 2004908564, 2005617264, 2006339564.
Verify the product code P4P16TSD and lot numbers listed in the recall notice.
The temperature sensors may not measure body temperature within the required tolerance of +/- 0.2°C, which could lead to incorrect diagnoses and insufficient treatment.
The recall notice does not specify a remedy, so contact the manufacturer for guidance on next steps.
Lot numbers 1826714264, 1908533364, 1909302964, 1909303064, 1910654864, 1911300664, 1916240464, 1921106564, 1922533864, 2004908564, 2005617264, 2006339564.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1990-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1990-2020 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.
