AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 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.
Reported: August 3, 2016 Initiated: June 22, 2016 #Z-2286-2016
Product Description
AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 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.
Reason for Recall
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.
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 40 units (6-Pack)
- Distribution
- US Nationwide Distribution
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 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.. Recalled by LeMaitre Vascular, Inc.. Units affected: 40 units (6-Pack).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Moderate. Recall number: Z-2286-2016.
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