Events

Recall of Device Recall Medline Dressing Change Tray with CloraPrep

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
    25572
  • Event Risk Class
    Class 2
  • Event Number
    Z-0645-03
  • Event Initiated Date
    2003-02-12
  • Event Date Posted
    2003-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26339
  • 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
    Wound Dressing Kit - Product Code MCY
  • Reason
    Some of the kits labeled as latex free contain latex gloves which are properly labeled.
  • Action
    Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.

Device

Device Recall Medline Dressing Change Tray with CloraPrep
  • Model / Serial
    reorder #DYND75221, lot 02KA0269
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays per case
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, One Medline Place, Mundelein IL 60060
  • Source
    USFDA