Oscor, Inc. recalls OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters…

Recall date

October 5, 2016

Source

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

Recall number

Z-0810-2017

FDA classification

Class II

Brand / firm

Oscor, Inc.

Sold / distributed

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

Why it was recalled

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

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

What was recalled

OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.