Resource Optimization & Innovation Llc recalls Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
- Recall date
- August 19, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2798-2015
- FDA classification
- Class II
- Brand / firm
- Resource Optimization & Innovation Llc
- Sold / distributed
- Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
Why it was recalled
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack 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 Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
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