Medical device recalls Moderate risk

Arrow International product recalled over labeling errors

Recall date
July 7, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Arrow International Inc recalls Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Recall number
Z-2911-2016
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
US Nationwide Distribution

Why it was recalled

Arrow is recalling due to incorrect labeling of products.

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

What was recalled

Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.

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