Arrow International Inc recalls The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Se…

Recall date

February 4, 2013

Source

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

Recall number

Z-1007-2015

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Worldwide Distribution -- US and Canada.

Why it was recalled

The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

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

What was recalled

The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.