Z-1436-2013 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2013
- Initiation Date
- May 13, 2013
- Termination Date
- August 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53
Product Description
Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
Reason for Recall
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
Code Information
Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845