FDADecember 22, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
applied medical resourcesappliedapplied medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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