Stryker Sustainability Solutions product recalled over labeling errors

Recall date

April 28, 2016

Source

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

Official notice title

Stryker Sustainability Solutions recalls Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for tem…

Recall number

Z-1708-2016

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

Distributed in the state of NY and the country of Canada.

Why it was recalled

Mislabeled for size

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

What was recalled

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.