FDA (Devices) recall action 83026
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
The agency’s own wording, quoted from the enforcement report.
Zyno Medical LLC is recalling administration sets where an inverted pinch clamp may cause blood to be drawn from the patient instead of delivering fluid.
Zyno Medical LLC is recalling administration sets with inverted pinch clamps that may cause blood to be drawn from patients instead of delivering fluid.