Z-0805-2017 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
- 110
Product Description
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 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: C1-09848 Exp. March 4, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, C1-09099 Exp. July 15, 2017, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017, C1-09848 Exp. March 4, 2018, C1-10382 Exp. May 17, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, OR-04730 Exp. October 29, 2018, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017 and C1-09848 Exp. March 4, 2018