FDAFDA · Food and drugs·Recall number Z-2284-2016
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Published August 3, 2016 · Recall initiated: June 22, 2016
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
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LeMaitre Vascular, Inc.
- Distributor
- US Nationwide Distribution
- Lot
- Lot Numbers: ANC1549¿ ANC1612¿ ANC1678¿ ANC1679¿ ANC1682¿ ANC2001¿ ANC2008¿ ANC2009¿ ANC2013¿ ANC2015¿ ANC2016¿ ANC2017¿ ANC2018¿ ANC2019¿ ANC2020¿ ANC2021¿
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.