FDA (Devices) recall action 89760
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.
Due to an increase in complaint trend for leaks and intermittent/loose connections.
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.
Abbott Vascular is recalling seven lots of the Plus 30 Priority Pack due to increased reports of leaks and intermittent loose connections in the vascular devices.
Abbott Vascular recalls 20/30 Indeflator medical devices due to increased complaints of leaks and loose connections. The recall affects 17 product lots distributed nationwide and internationally.
Abbott Vascular is recalling the 20/30 Priority Pack w/COPILOT device due to an increase in complaints of leaks and loose connections. The recall affects 131 lots distributed nationwide and internationally.
Abbott Vascular is recalling INDEFLATOR Plus 30 balloon inflators due to increasing complaints of leaks and intermittent loose connections that could affect device function during medical procedures.
Abbott Vascular is recalling 23 lots of Priority Pack accessory kits and packs due to reports of leaks and loose connections in the devices.