Covidien recalls specific urine collection trays due to potential temperature measurement errors that could lead to incorrect diagnoses and inadequate treatment. Affected units have lot numbers starting with 1914133564.
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 urine collection tray because its temperature sensor might not work correctly. This could lead to inaccurate body temperature readings and improper medical treatment. The recall affects units with lot numbers starting with 1914133564.
The temperature sensor in the tray may not measure body temperature within the required accuracy range of +/- 0.2°C. This could result in incorrect temperature readings, potentially leading to misdiagnosis and inadequate treatment for patients.
Patients using this specific urine collection tray for drainage and temperature monitoring. Healthcare providers who use the product for prescription purposes are most at risk.
Check for lot numbers starting with 1914133564 on the product. The product includes a 400 ml silicone tray with a temperature sensor and 5 mL catheter.
Look for lot numbers starting with 1914133564 on the product packaging.
The temperature sensor may not measure body temperature within the required +/- 0.2°C tolerance, which could lead to incorrect diagnoses and insufficient treatment.
Check the product lot number. If it starts with 1914133564, contact the manufacturer for further instructions.
The recall is due to potential measurement errors, not direct injury risks. The danger level is low risk as it relates to diagnostic accuracy, not physical harm.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1994-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1994-2020 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.
