FDA recall Z-1772-2018

Bard Peripheral Vascular Inc · Class II · device

Product

POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Completed
Initiation date: 2018-02-08
Report date: 2018-05-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1772-2018