Arrow International Inc recalls 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.

Recall date

September 18, 2015

Source

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

Recall number

Z-0127-2016

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.

Why it was recalled

Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.

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

What was recalled

4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.