Home / Recalls / Resource Optimization & Innovation Llc / Z-0169-2018

Z-0169-2018 Class II Ongoing

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

Recall Details

Product Type
Devices
Report Date
November 29, 2017
Initiation Date
September 25, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51 units

Product Description

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

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.

Distribution Pattern

Distributed domestically to Texas.

Code Information

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

Other recalls by Resource Optimization & Innovation Llc

  • Z-0950-2022 Class II — Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous (February 28, 2022)
  • Z-2699-2020 Class II — regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576RE (June 17, 2020)
  • Z-2368-2020 Class II — Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Fl (May 4, 2020)
  • Z-2369-2020 Class II — Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush (May 4, 2020)
  • Z-1652-2017 Class II — Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn (January 9, 2017)
  • Z-1675-2017 Class II — Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa (January 9, 2017)
  • Z-1553-2017 Class II — Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hill (January 9, 2017)
  • Z-1589-2017 Class II — Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills (January 9, 2017)
  • Z-1635-2017 Class II — Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highla (January 9, 2017)
  • Z-1608-2017 Class II — Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center (January 9, 2017)