Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-0169-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 25, 2017

Date Posted: November 29, 2017

Recall Number: Z-0169-2018

Event ID: 78377

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 51 units

Code Information:

Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019

Distribution Pattern:

Distributed domestically to Texas.

Voluntary or Mandated:

Voluntary: Firm initiated