FDA (Devices) recall action 68744
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.
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
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.
DeRoyal Industries is recalling 128 Knee Arthroscopy Packs because they contain Irrigation Sets previously recalled by Hospira.
DeRoyal is recalling Cardiac Hypothermia Trays because they contained irrigation sets previously recalled by Hospira.