Events

Recall of Gas Bottle Holder HKH 8880

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

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
    79811
  • Event Risk Class
    Class 2
  • Event Number
    Z-1642-2018
  • Event Initiated Date
    2018-04-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163499
  • 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
    Accessory equipment, cardiopulmonary bypass - Product Code KRI
  • Reason
    There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
  • Action
    The Urgent Medical Device Recall Removal letter was distributed on 4/4/18. The letter instructed the customer to: Please examine your inventory for the affected 701050901 Gas Bottle Holder HKH 8880 and immediately remove it from use. Please contact your Getinge representative or call the Maquet/Getinge Customer Support at +1 (888) 627-8383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit. Please complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to fieldactions@maquet.com or by faxing the form to +1 (973) 629-1655.

Device

Gas Bottle Holder HKH 8880
  • Model / Serial
    US: 98880-020  Foreign: 98880 - 002, 98880 - 004, 98880 - 005, 98880 - 006, 98880-009, 98880-010, 98880-011, 98880-012, 98880- 013, 98880-014, 98880-016, 98880-017, 98880-018
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
  • Product Description
    CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 || Product Usage: || The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
  • Manufacturer
    Maquet Cardiopulmonary Ag

Manufacturer

Maquet Cardiopulmonary Ag
  • Manufacturer Address
    Maquet Cardiopulmonary Ag, Kehler Strasse 31, Rastatt Germany
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA