Stryker Neurovascular recalls Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00…

Recall date

November 13, 2018

Source

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

Recall number

Z-0065-2020

FDA classification

Class II

Brand / firm

Stryker Neurovascular

Sold / distributed

OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland

Why it was recalled

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

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

What was recalled

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771