Arrow International Inc recalls Arrow Glide Thru Peel-Away Sheath/Dilator Introducer

Recall date

June 12, 2017

Source

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

Recall number

Z-2699-2017

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok

Why it was recalled

Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the 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

Arrow Glide Thru Peel-Away Sheath/Dilator Introducer