FDA-Device2018-05-16Class II

POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

Bard Peripheral Vascular Inc

Hazard

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

Sold states

Nationwide

Affected count

359 units

Manufactured in

1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States

Products

POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1760-2018

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