The Recall Desk

FDA (Devices) recall action 74563

LeMaitre Vascular, Inc. recalled 7 products on 2016-08-03

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2016-08-03
Critical
0
Units
956

Why these products were 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

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • ModerateFDA (Devices)··2016-08-03

    LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.

    Product
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.

    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 titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.

    Product
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    LeMaitre Vascular Recalls Anasto AC Closure System for Mislabeling

    LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is…
    Category
    Distribution
    0 states