Events

Recall of Device Recall MedikMark and Maxxim

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

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
    29579
  • Event Risk Class
    Class 2
  • Event Number
    Z-1138-04
  • Event Initiated Date
    2004-07-12
  • Event Date Posted
    2004-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34151
  • 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 tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
  • Action
    Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.

Device

Device Recall MedikMark and Maxxim
  • Model / Serial
    reoder no. SR-2005: lots 308045, 309064, 310137, 406019;  reorder no. SD-2005: lots 201107, 203003, 204020, 205035, 205172, 207044, 207101, 208125, 210016, 211007, 301006, 302090, 304070, 305043, 306201, 307075, 308071, 309034, 310124, 312017, 401065, 404004
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: || a) Medikmark inc. Staple Removal Set, reorder no. SR-2005, 3600 Bur Wood Drive, Waukegan, IL 60085; || b) Maxxim Medical Staple Removal Kit, reorder no. SD-2005, Distributed by Maxxim Medical, Oldsmar, FL 34677.
  • Manufacturer
    Medikmark, Incorporated

Manufacturer

Medikmark, Incorporated
  • Manufacturer Address
    Medikmark, Incorporated, 3600 Burwood Dr, Waukegan IL 60085-8399
  • Source
    USFDA