Events

Recall of INFINITY DUAL HEMO MCable Pod

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draegar Medical Systems, 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
    79209
  • Event Risk Class
    Class 2
  • Event Number
    Z-0942-2018
  • Event Initiated Date
    2017-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161659
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dr¿ger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
  • Action
    In September of 2017 an Urgent medical Device Recall letter was issued to customers informing them of the recall and to request that inventory be checked to see if the product subject in the recall is on the premises. To do this, the customer will check the label for the revision index number which is located on the upper middle portion of label. RI number 15 and 16 are included in the recall. No other numbers are subject to recall. Affected product will receive a sleeve from the company to correct the issue. Questions or concerns can be directed to 1-800-437-2437 (Press 1, then press 32349) or contact Customer Care at 1-800-437-2437 (Press 4, then press 4 again)

Device

INFINITY DUAL HEMO MCable Pod
  • Model / Serial
    Have the affected revision indexes: 15 or 16 (found on the product label)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    INFINITY DUAL HEMO MCable Pod
  • Manufacturer
    Draegar Medical Systems, Inc.

Manufacturer

Draegar Medical Systems, Inc.
  • Manufacturer Address
    Draegar Medical Systems, Inc., 6 Tech Dr, Andover MA 01810-2434
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA