Recalls / —

—#139572

Product

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

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

023735

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

On 8/19/2015, the recalling firm sent its two consignees an email with the recall notice attached. The notice notified their customers that they were affected by the recalling firm's supplier's recall. The notice instructed the customers to dispose of the recalled component and acknowledge receipt of the recall notice.

Recalling firm

Firm

Resource Optimization & Innovation Llc

Address

2909 N Neergard Ave, Springfield, Missouri 65803

Distribution

Distribution pattern

Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.

Timeline

Recall initiated

2015-08-19

Posted by FDA

2015-09-21

Terminated

2017-04-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #139572. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.