Arrow International Inc recalls 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2

Recall date

July 17, 2018

Source

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

Recall number

Z-3200-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.

Why it was recalled

The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.

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

What was recalled

5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2