FDA recall Z-0582-2020

Bard Peripheral Vascular Inc · Class II · device

Product

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

Reason for recall

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

Distribution

US - Nationwide OUS - None

Key facts

Status
Ongoing
Initiation date
2019-02-14
Report date
2019-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

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