FDAClass IIAugust 3, 2016

AnastoClip AC 8cm 35 Clips recall

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…

Why was AnastoClip AC 8cm 35 Clips recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: ANC1549¿ ANC1612¿ ANC1678¿ ANC1679¿ ANC1682¿ ANC2001¿ ANC2008¿ ANC2009¿ ANC2013¿ ANC2015¿ ANC2016¿ ANC2017¿ ANC2018¿ ANC2019¿ ANC2020¿ ANC2021¿

Product
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…
Recalling firm
LeMaitre Vascular, Inc.
Quantity
471 units
Distribution
US Nationwide Distribution
Recall date
August 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls