Recall Z-2798-2015— Resource Optimization & Innovation Llc

Name: FDA recall Z-2798-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-19

Class II · Terminated

Class II FDA medical device recall by Resource Optimization & Innovation Llc, initiated 2015-08-19, terminated 2017-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.. Reason: Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance..

Recalling firm: Resource Optimization & Innovation Llc
Classification: Class II
Status: Terminated
Initiated: 2015-08-19
Terminated: 2017-04-05
Firm location: Springfield, MO, United States

Product description

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

Reason for recall

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.