Events

Recall of Device Recall Medline Industries Inc.

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
    71720
  • Event Risk Class
    Class 2
  • Event Number
    Z-2433-2015
  • Event Initiated Date
    2015-07-08
  • Event Date Posted
    2015-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138826
  • 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
    Razor, surgical - Product Code LWK
  • Reason
    Charging base of surgical clippers overheats and smokes.
  • Action
    Medline Industries sent a " Urgent Remedial Action Destruction Form " letter via first class dated July 9, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. ***URGENT RECALL IMMEDIATE ACTION REQUIRED SURGICAL CLIPPER CHARGER BASE DYND70800 *** Medline Industries, Inc. is recalling specific lots of the Medline Surgical Clippers Charger Base (base only). This recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction. These lots were distributed October 2013 through March 2015. After further investigation we have determined the root cause to be a defective circuit board. This defect has since been corrected. REQUIRED ACTION: 1. Immediately check your stock for item number DYND70800 and the affected lots listed on the destruction form, dispose of the affected charger base only (do not dispose of the clipper). 2. Please return the completed enclosed destruction form listing the quantity of affected charger base(s) you destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form we will send you replacement charger base(s). 3. If you are a distributor, promptly notify any of your customers that may have received affected product. If you have any questions, please contact 866-359-1704. As the distributor of this product, we sincerely regret the inconvenience. We, like you, place the health and safety of your patients first and foremost. This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Device

Device Recall Medline Industries Inc.
  • Model / Serial
    Product item number: DYND70800 with Lot Numbers: 13F1, 13KD, 14A1, 14C1, and Lot 1.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : United Arab Emirates, Barbados, Bahamas, Chile, Costa Rica, Italy, Lebanon, and Singapore.
  • Product Description
    Medline Electrical Clipper with Charging base || The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.
  • 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