Resource Optimization & Innovation Llc recalls Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.

Recall date

August 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0190-2016

FDA classification

Class II

Brand / firm

Resource Optimization & Innovation Llc

Sold / distributed

Distributed in Texas and Louisiana.

Why it was recalled

Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.