Covidien recalls P400 PREM U/M 16FR TMPSNS with defective temperature sensors that may show lower body temperature than actual. Affected units have item code P4P16TS.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Covidien is recalling temperature sensors that may show lower body temperature readings than actual. This could lead to incorrect medical decisions if used in patient monitoring.
Defective temperature sensors may show lower body temperature than actual. This could lead to incorrect medical decisions if used in patient monitoring. The hazard is specific to medical device use.
Healthcare professionals using these sensors for patient temperature monitoring. Patients receiving care with these devices may be at risk of inaccurate temperature readings.
Look for the item code P4P16TS on the device. The product name is P400 PREM U/M 16FR TMPSNS. This recall applies to devices sold with the item code P4P16TS.
Verify the item code on the device is P4P16TS.
The temperature sensors may show a lower body temperature measurement than the actual temperature of the patient.
Look for the item code P4P16TS on the device. The product name is P400 PREM U/M 16FR TMPSNS.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-3208-2018 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-3208-2018 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.
