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Resource Optimization & Innovation Llc recalls Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical proced
Recalled September 30, 2015 · FDA recall Z-2799-2015 · Resource Optimization & Innovation
Hazard
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. · FDA Class II
Units
67 kits
Sold at
Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
Description
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Product
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Manufacturer(s)
Resource Optimization & Innovation Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →