Z-0806-2017 Class II Terminated
FDA device recall Z-0806-2017 was initiated by Oscor, Inc. on Oct 5, 2016 and is designated Class II. 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. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2016
- Initiation Date
- Oct 5, 2016
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
OSCOR ADELANTE BREEZEWAY 10F C120¿ 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: OR-04725 Exp. October 20, 2018, C1-10042 Exp. April 5, 2018, C1-10042 Exp. April 5, 2018, and C1-11868 Exp. October 20, 2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0806-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026