Events

Recall of Regard Custom Surgical Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Resource Optimization & Innovation Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78377
  • Event Risk Class
    Class 2
  • Event Number
    Z-0169-2018
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159384
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    General surgery tray - Product Code LRO
  • Reason
    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.
  • Action
    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

Device

Regard Custom Surgical Pack
  • Model / Serial
    Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed domestically to Texas.
  • Product Description
    Regard Custom Surgical Pack || Packs contain surgical instruments and accessories intended for use during a surgical procedure.
  • Manufacturer
    Resource Optimization & Innovation Llc

Manufacturer

Resource Optimization & Innovation Llc
  • Manufacturer Address
    Resource Optimization & Innovation Llc, 2909 N Neergard Ave, Springfield MO 65803-6317
  • Source
    USFDA