Reported Sep 26, 2018 · Terminated
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: COVIDIEN LLC · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
- Lot codes and dates
- 1733152764 1806451564
- Amount recalled
- 27515 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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