FDA recall Z-0179-2018

Product

Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

Reason for recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Distribution

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

Key facts

Status

Terminated

Initiation date

2017-06-01

Report date

2017-12-06

Termination date

2020-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0179-2018