FDA (Devices) recall action 83738
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.
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
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.
Merit Medical Systems is recalling 88 Custom Procedure Kits because they were incorrectly labeled as latex-free.
Merit Medical Systems is recalling 24 Vein Procedure Kits because they were incorrectly labeled as latex-free.