FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
Brand
Resource Optimization & Innovation Llc
UPC
023735

Units Affected

24 kits