FDA-Device2019-12-04Class II

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Bard Peripheral Vascular Inc
Hazard

Complaints received that products packaged with the incorrect introducer sheath size.

Sold states
US - Nationwide OUS - None
Affected count
900 units
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2020

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