Home / Recalls / Medical Devices
Oscor, Inc. recalls OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters
Recalled December 28, 2016 · FDA recall Z-0810-2017 · Oscor
Hazard
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. · FDA Class II
Units
255
Sold at
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
Description
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Product
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.
Manufacturer(s)
Oscor, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →