Events

Recall of Device Recall 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
    72008
  • Event Risk Class
    Class 2
  • Event Number
    Z-2798-2015
  • Event Initiated Date
    2015-08-19
  • Event Date Posted
    2015-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139572
  • 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 (kit) - Product Code LRO
  • Reason
    Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
  • Action
    On 8/19/2015, the recalling firm sent its two consignees an email with the recall notice attached. The notice notified their customers that they were affected by the recalling firm's supplier's recall. The notice instructed the customers to dispose of the recalled component and acknowledge receipt of the recall notice.

Device

Device Recall Regard Custom Surgical Pack
  • Model / Serial
    23735
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
  • Product Description
    Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
  • Manufacturer
    Resource Optimization & Innovation Llc

Manufacturer

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