Events

Recall of Device Recall Regard

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
    76255
  • Event Risk Class
    Class 2
  • Event Number
    Z-1656-2017
  • Event Initiated Date
    2017-01-09
  • 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=153161
  • 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
    Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
  • Action
    ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.

Device

Device Recall Regard
  • Model / Serial
    035084B Exp Date 2018-07-13; 038325B Exp Date 2018-09-22; 039576B Exp Date 2018-11-12
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to LA and TX.
  • Product Description
    Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
  • 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