Z-0795-2017 Class II Terminated
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
- 76
Product Description
OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 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: C1-09374 Exp. November 5, 2017, C1-10319 Exp. May 11, 2018, C1-11202 Exp. August 24, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11671 Exp. September 30, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11672 Exp. September 30, 2018, and C1-09374 Exp. November 5, 2017