FDAFDA · Food and drugs·Recall number Z-1436-2013
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.
Published June 19, 2013 · Recall initiated: May 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Endologix Inc
- Distributor
- Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
- Lot
- Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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