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 Anastoclip AC Clip Applier.
Reported: August 3, 2016 Initiated: June 22, 2016 #Z-2283-2016
Product Description
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 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
- 256 units
- Distribution
- US Nationwide Distribution
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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 Anastoclip AC Clip Applier.. Recalled by LeMaitre Vascular, Inc.. Units affected: 256 units.
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-2283-2016.
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