FDA (Devices) recall action 87431
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
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.
Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the product to stick, preventing proper application.
Cardinal Health is recalling non-sterile femoral angiography drapes because a manufacturing defect causes them to stick, preventing proper application.
Cardinal Health is recalling In-View Clear Leggings Sterile because a manufacturing variance causes the plastic film to stick, potentially preventing proper application.
Cardinal Health is recalling 936 units of sterile femoral angiography drapes because a manufacturing variance causes the plastic film to stick, preventing proper application.
Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the plastic film to stick, preventing proper application.