Events

Recall of Medline Blue O.R. Towel

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
    27507
  • Event Risk Class
    Class 2
  • Event Number
    Z-0114-04
  • Event Initiated Date
    2003-10-07
  • Event Date Posted
    2003-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29984
  • 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
    Drape, Surgical - Product Code KKX
  • Reason
    The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
  • Action
    Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned product.

Device

Medline Blue O.R. Towel
  • Model / Serial
    Reorder #MDT2168204, lot 03IA0532
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Ohio, Iowa, Illinois, Wisconsin and Indiana
  • Product Description
    Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA