Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Regard Custom Surgical Pack Recalled by Resource Optimization & Innovation Llc Due to Surgical kits contain a surgical scrub product which...

Date: August 19, 2015
Company: Resource Optimization & Innovation Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Resource Optimization & Innovation Llc directly.

Affected Products

Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.

Quantity: 67 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 2 states: LA, SC

Affected (2 states)Not affected

About Resource Optimization & Innovation Llc

Resource Optimization & Innovation Llc has 224 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report