Events

Recall of Device Recall Drager Medical Air Compressor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, 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
    37188
  • Event Risk Class
    Class 2
  • Event Number
    Z-0674-2007
  • Event Initiated Date
    2007-01-26
  • Event Date Posted
    2007-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50072
  • 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
    Medical Air Compressor - Product Code BTI
  • Reason
    Compressors not providing sufficient supply pressure to connected medical ventilator.
  • Action
    The recalling firm issued a Medical Device Recall Letter dated 1/22/07 to their customers via Certified Mail. An authorized service representative will inspect each potentially affected device. If a device is found to have an affected dryer assembly, it will be repaired free of charge.

Device

Device Recall Drager Medical Air Compressor
  • Model / Serial
    Model number 8413419. Catalog number 8413419. Serial Numbers ARXC-001; ARXC-0002; ARXC-0009; ARXC-0011; ARXC-0012; ARXC-0013; ARXC-0014; ARXC-0015; ARXC-0016; ARXC-0017; ARXC-0019; ARXC-0020; ARXD-0034; ARXD-0035; ARXD-0036; ARXD-0037; ARXD-0038; ARXD-0039; ARXD-0040; ARXE-0081; ARXE-0082; ARXE-0083; ARXE-0084; ARXE-0085; ARXE-0086; ARXE-0087; ARXE-0088; ARXE-0089; ARXE-0090; ARXE-0091; ARXE-0092; ARXE-0093; ARXE-0094; ARXE-0095; ARXE-0096; ARXE-0097; ARXE-0098; ARXE-0099; ARXE0100; ARXE-0101; ARXE-0102; ARXE-0103; ARXE-0104; ARXE-0106; ARXE-0107; ARXE-0108; ARXE-0109; ARXE-0110; ARXE-0111; ARXE-0112; ARXE-0113; ARXE-0114; ARXE-0115; ARXE-0116; ARXE-0117; ARXE-0118; ARXE-0119; ARXE-0120; ARXE-0121; ARXE-0122; ARXE-0123; ARXE-0124; ARXE-0125; ARXE-0126; ARXE-0127; ARXE-0128; and ARXE-0129.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Medical Air Compressor || Model #8413419
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA