FDA recall Z-1763-2018

Bard Peripheral Vascular Inc · Class II · device

Product

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

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-1763-2018