Z-3042-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2018
- Initiation Date
- June 19, 2018
- Termination Date
- April 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
Reason for Recall
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
Distribution Pattern
Distributed to accounts in FL, NV, OK, SC, and TX.
Code Information
AGC2134