Recall Z-1436-2013— Endologix Inc
Class I · Terminated
Class I FDA medical device recall by Endologix Inc, initiated 2013-05-13, terminated 2013-08-19. It names one FDA 510(k) clearance: K120212. 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: Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures..
- Recalling firm
- Endologix Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-05-13
- Terminated
- 2013-08-19
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.