Endologix Inc Recall: Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers
Endologix Inc Recall: Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Endologix Inc; Product: Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: Th
| Recalling firm | Endologix Inc |
|---|---|
| Product | 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| 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. |
| Recall initiated | 20130513 |
| Recall number | Z-1436-2013 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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