FDA (Devices) recall action 95306
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 convenience kits containing a kit component that is under a recall action for improper use.
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.
Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.
The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.
Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.
Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.
Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.