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
  • 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
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

  • Model / Serial
    reorder no. RS-2000: lot 304075; reorder no. SR-2000: lots 201106, 205173, 209014, 210017, 211084, 301059, 303069, 305096, 305143, 308044, 310136, 311136, 312059, 401132, 404160, 405062, 406018; reorder no. SD-2000: lot 204019
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: || a) Medikmark inc. Staple Removal Tray, reorder no. RS-2000, 3600 Bur Wood Drive, Waukegan, IL 60085; || b)Medikmark Inc. Staple Removal Set, reorder no. SR-2000; 3600 Bur Wood Drive, Waukegan, IL 60085; || c) Maxxim Medical Staple Removal Kit, reorder no. SD-2000, Distributed by Maxxim Medical, Oldsmar, FL 34677.
  • Manufacturer