The Recall Desk

FDA (Devices) recall action 73456

Applied Medical Resources Corp recalled 4 products on 2016-04-13

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-04-13
Critical
0
Units
1,771

Why these products were recalled

Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2016-04-13

    Applied Medical Resources Recalls Epix Universal Clip Applier Kits

    Applied Medical Resources is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··2016-04-13

    Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Defect

    Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··2016-04-13

    Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Mechanism Defect

    Applied Medical Resources Corp is recalling CA500 Epix Universal Clip Appliers due to a potential loading mechanism nonconformance. The recall affects 1,771 units distributed in the U.S. and internationally.

    Product
    CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··2016-04-13

    Applied Medical Resources Recalls Epix Universal Clip Applier Kits

    Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Distribution
    13 states