Stryker Sustainability Solutions recalls Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiologi…

Recall date

August 23, 2018

Source

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

Recall number

Z-0467-2019

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

US: KS OUS: None

Why it was recalled

Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.

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 Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.