Medical device recalls Moderate risk

Arrow International Inc recalls Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-…

Recall date
May 9, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2328-2017
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
Worldwide Distribution - US (nationwide) and Canada

Why it was recalled

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

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

What was recalled

Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation

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