FDA (Devices) recall action 72052
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting 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 77 custom cardiovascular surgical kits because a component's compromised packaging may affect sterility assurance.
Resource Optimization & Innovation LLC is recalling 28 custom cardiovascular surgical kits because a component had compromised package integrity, potentially affecting sterility.
Resource Optimization & Innovation LLC is recalling 84 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.
Resource Optimization & Innovation LLC is recalling 80 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.
Resource Optimization & Innovation LLC is recalling 153 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.
Resource Optimization & Innovation LLC is recalling 17 custom surgical kits in Texas and Louisiana because a component was recalled for compromised package integrity, potentially affecting sterility.
Resource Optimization & Innovation LLC is recalling 10 custom surgical kits distributed in Texas and Louisiana because compromised package integrity may affect sterility.