Z-0804-2017 Class II Terminated
FDA device recall Z-0804-2017 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: 124.
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
- 124
Product Description
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 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: C1-08611 Exp. February 20, 2017, C1-09397 Exp. November 17, 2017, C1-09408 Exp. November 25, 2017, C1-09408 Exp. November 25, 2017, C1-09861 Exp. March 5, 2018, C1-09858 Exp. March 5, 2018, C1-09861 Exp. March 5, 2018, C1-10901 Exp. July 19, 2018, C1-11205 Exp. August 24, 2018, C1-11205 Exp. August 24, 2018, C1-12250 Exp. January 4, 2019, C1-08611 Exp. February 20, 2017, and C1-11205 Exp. August 24, 2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0804-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026