Events

Recall of Device Recall Medline Open Heart CDS Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries, Inc..

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
    31528
  • Event Risk Class
    Class 2
  • Event Number
    Z-0769-05
  • Event Initiated Date
    2005-03-18
  • Event Date Posted
    2005-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38085
  • 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
    The procedure packs contain anesthesia/breathing circuits being recalled by mms sales due to partial occlusion of the t-piece resulting in airway obstruction.
  • Action
    Recalled from the direct account hospitals via letter dated 3/18/05 and 3/23/05. The letters informed the accounts of the occlusion via copy of the MMS recall letter, and listed the Medline reorder number and lot numbers of the custom packs shipped to them, along with the MMS part number contained there in. The accounts were requested to examine their stocks for the affected codes and return them to Medline.

Device

Device Recall Medline Open Heart CDS Kit
  • Model / Serial
    reorder number CDS840144A, lots 04JD2847, 04LD2995, 05AD3946, 05BD0929, 05BD4100
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Alabama, Minnesota, Florida and Indiana.
  • Product Description
    Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
  • Manufacturer
    Medline Industries, Inc.

Manufacturer

Medline Industries, Inc.
  • Manufacturer Address
    Medline Industries, Inc., 1170 S Northpoint Blvd, Waukegan IL 60085-6757
  • Source
    USFDA