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
    72052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0189-2016
  • Event Initiated Date
    2015-08-25
  • Event Date Posted
    2015-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139795
  • 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
    Warmer, irrigation solution - Product Code LHC
  • Reason
    Custom surgical kits contain a component (ors fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
  • Action
    On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.

Device

Device Recall Regard

Manufacturer

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