Reported Jun 19, 2013 · Terminated
Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product…
Endologix Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Endologix Inc · 11 Studebaker · Irvine, CA · 92618-2013
Is this the product you have?
- Brand NameAFX" Introducer System, Model Number S17-45
- Lot Numbers
1079840107984310798441079845
- Product UsageThe 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
- Lot codes and dates
- Model Number S17-45
- Lot Numbers
1079840107984310798441079845
- Amount recalled
- 53
Where it was sold
Why it was recalled
Stop using this product now
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Endologix Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.