Covidien recalls specific urine collection trays due to potential temperature measurement errors that could lead to incorrect diagnoses and inadequate treatment. Affected units have unique lot numbers and are prescription-only medical devices.
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 urine collection trays because their temperature sensors might not read patient body temperatures accurately. This could lead to wrong diagnoses and inadequate treatment if the temperature readings are incorrect.
The temperature sensors in these trays may not measure body temperature within the required tolerance of +/- 0.2°C. This could result in incorrect temperature readings, potentially leading to misdiagnosis and insufficient treatment for patients.
Healthcare professionals and patients using prescription urine collection systems with the specific model and lot numbers listed. Those with the product code P4P14TSD are most at risk.
Check for the product code P4P14TSD on the tray. Look for lot numbers 1909308464 or 1933000164. These are prescription-only medical devices sold for urinary drainage with temperature monitoring.
Identify the product code P4P14TSD and lot numbers 1909308464 or 1933000164 on the tray.
The temperature sensors 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 numbers to see if it's affected. If it is, contact your healthcare provider for guidance.
The recall record does not mention any remedy or fix for this product.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1988-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1988-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
