Z-0791-2017 Class II Terminated
FDA device recall Z-0791-2017 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: 87.
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
- 87
Product Description
OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 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: C1-12312 Exp. January 18, 2019, OR-04686 Exp. July 16, 2018, Exp. April 21, 2015, OR-04655 Exp. April 20, 2018, C1-10985 Exp. July 28, 2018, OR-04686 Exp. July 16, 2018, C1-12312 Exp. January 18, 2019, C1-12312 Exp. January 18, 2019, and OR-04655 Exp. April 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-0791-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026