Home / Recalls / Oscor, Inc. / Z-0810-2017

Z-0810-2017 Class II Terminated

Recalled by Oscor, Inc. — Palm Harbor, FL

Recall Details

Product Type
Devices
Report Date
December 28, 2016
Initiation Date
October 5, 2016
Termination Date
July 26, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
255

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot #'s: C1-08260 Exp. October 6, 2016 and C1-08283 October 14, 2016

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  • Z-0812-2017 Class II — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catal (October 5, 2016)