Recall Z-1436-2013 ยท DYB Introducer, Catheter
Endologix Inc
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.
| Date | Jun 7, 2013 (initiated May 13, 2013) |
| Status | Terminated |
| Reason | Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures. |
| Root cause | Nonconforming Material/Component |
| Action | Endologix Inc sent an "URGENT-MEDICAL DEVICE RECALL NOTICE" letters dated May 13, 2013 to all affected customers. The letter identified the affected product, reason for recall, and actions to be taken. The letter instructed customers to do not use or further distribute any affected product. The letter instructed customers to share this information with physicians that perform these procedures at the facility. The firm will call to confirm that this device is located at the facility. After confirmation the firm will retrieve the device. For questions call (800) 983-2284. |
| Quantity | 53 |
| Distribution | Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120212 | AFX INTRODUCER SYSTEM Endologix, Inc., Feb 9, 2012 |