Arrow International Inc recalls Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectab…

Recall date

December 13, 2018

Source

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

Recall number

Z-1366-2019

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC

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 PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.