FDA (Devices) recall action 72008
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.
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
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.
Resource Optimization & Innovation Llc is recalling 24 Regard Custom Surgical Packs because they may contain chemically contaminated scrub products and lack sterility assurance.
Resource Optimization & Innovation Llc is recalling 67 Regard Custom Surgical Packs due to potential chemical contamination and lack of sterility assurance.