FDA (Devices) recall action 90492
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.
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
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.
ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.