FDA-Device2015-09-30Class II
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Resource Optimization & Innovation Llc
Hazard
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Sold states
Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
Affected count
67 kits
Manufactured in
2909 N Neergard Ave, N/A, Springfield, MO, United States
Products
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2799-2015Don't want to check this manually?
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