Arrow International Inc recalls Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS…

Recall date

June 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0179-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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