Product Wiki · Recalls · U.S. FDA — Device Enforcement

Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 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 Anastocl — recall Z-2283-2016

U.S. FDA — Device Enforcement · United States · 2016-06-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2283-2016
Date of alert: 2016-06-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: LeMaitre Vascular, Inc.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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