FDA (Devices) recall action 85436
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.
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
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.
Applied Medical Resources Corp is recalling 21 units of Dr. Thames Lap Chole laparoscopic graspers because a protruding rivet may cause tissue damage during use.
Applied Medical Resources Corp is recalling Epix latis GRASPER instruments because a protruding rivet may catch tissue and cause damage during use.
Applied Medical Resources Corp is recalling Epix latis GRASPER devices because a protruding rivet may cause tissue damage during use.
Applied Medical Resources Corp is recalling Clip Applier Kits because a protruding rivet on the laparoscopic grasper may catch tissue, causing damage.