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.
Reported: June 19, 2013 Initiated: May 13, 2013 #Z-1436-2013
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.
Details
- Recalling Firm
- Endologix Inc
- Units Affected
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Endologix Inc. Units affected: 53.
Why was this product recalled? ▼
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2013. Severity: Critical. Recall number: Z-1436-2013.
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