Home / Recalls / Medical Devices
Resource Optimization & Innovation Llc recalls Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Recalled November 4, 2015 · FDA recall Z-0184-2016 · Resource Optimization & Innovation
Hazard
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. · FDA Class II
Units
84 kits
Sold at
Distributed in Texas and Louisiana.
Description
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Product
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Manufacturer(s)
Resource Optimization & Innovation Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →