Z-0796-2017 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
- 61
Product Description
OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 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: OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, C1-11635 Exp. September 29, 2018, OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, and C1-09412 Exp. December 1, 2017