Z-0798-2017 Class II Terminated
FDA device recall Z-0798-2017 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: 26.
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
- 26
Product Description
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 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-04691 Exp. July 16, 2018, C1-11728 Exp. October 4, 2018, C1-09375 Exp. November 5, 2017 and C1-09375 Exp. November 5, 2017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0798-2017
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026