—#159384

Product

Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019

Why it was recalled

Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.

Root cause (FDA determination)

Error in labeling

Action the firm took

Customer was notified of the recall via email on September 25, 2017. Instructions included identify and quarantine any affected products, notify ROi by completing and returning the completed notification form, coordinating the issuance of supplemental labeling which will instruct the end user to remove and discard the recalled ChloraPrep at the time of use. For further questions, please call (417) 820-2793

Recalling firm

Firm: Resource Optimization & Innovation Llc
Address: 2909 N Neergard Ave, Springfield, Missouri 65803-6317

Distribution

Distribution pattern: Distributed domestically to Texas.

Timeline

Recall initiated: 2017-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159384. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.