Z-1174-2016 Class II Terminated
FDA device recall Z-1174-2016 was initiated by Cordis Corporation on Dec 31, 2015 and is designated Class II. Reason for recall: Incorrect cannula of the sheath introducer (smaller than intended). The recall status is terminated (terminated Aug 25, 2016). Affected quantity: 1,985 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2016
- Initiation Date
- Dec 31, 2015
- Termination Date
- Aug 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,985 units
Product Description
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
Reason for Recall
Incorrect cannula of the sheath introducer (smaller than intended).
Distribution Pattern
US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.
Code Information
Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1174-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026