Arrow International Inc recalls Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to perm…

Recall date

May 11, 2018

Source

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

Recall number

Z-2336-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.

Why it was recalled

The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.

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

What was recalled

Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.