Device Recall Atrium

  • Model / Serial
    Lot #s 10304307, 10307012, 10311125, 10311233, 10318739, 10327129, 10336323, 10336426
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
  • Product Description
    HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets, Increased Length by 6", || Atrium Code # 14724, || Size 24, || # Eyelets 18, || 10 per case
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

43 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number : ME215673 EXp: 2019/09
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AZ, CA, LA. IN, NC, TN, TX, VA
  • Product Description
    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) || Part Number: 15236
  • Manufacturer
  • Model / Serial
    All Lot Numbers With Expiration Date Prior To October 2019
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
  • Product Description
    Atrium Medical 16400 Express Mini 500 dry seal drain || Product Usage: || To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
  • Manufacturer
  • Model / Serial
    Lot Number: 242919, 242920
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
  • Product Description
    Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC || Reference: 4000-100N || Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
  • Manufacturer
  • Model / Serial
    Lot Number: 242896, 243292
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
  • Product Description
    Maquet Ocean Water Seal Chest Drain, Single Collection WAC || Reference: 2002-000 || Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.
  • Manufacturer
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