Events

Recall of Multi Absorber Original, Disposable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

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
    66638
  • Event Risk Class
    Class 1
  • Event Number
    Z-0472-2014
  • Event Initiated Date
    2013-09-19
  • Event Date Posted
    2013-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122872
  • 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
    Absorber, carbon-dioxide - Product Code BSF
  • Reason
    Ge healthcare has recently become aware of a potential safety issue due to air leakage associated with the co2 multi absorber.
  • Action
    GE issued an Urgent Medical Device Correction letter dated September 19, 2013, to all affected customers via Fed Ex overnight mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected product, isolate all affected product and return the attached form via fax to 800-535-7923. Once the information is received, customers would be contacted with an RMA and replacement information. If product was distributed further the notice should be forwarded to those customers. For questions customers should call 1-800-345-2700, option 2 followed by ooption 2. For foreign customers 1-800-932-0760, option 2. For questions regarding this recall call 262-513-4122. GE issued a press release on 12/30/2013.

Device

Multi Absorber Original, Disposable
  • Model / Serial
    product number M1173310 containing lot numbers 12001 through 13031.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.
  • Product Description
    Multi Absorber Original, Disposable || M1173310 Multi Absorber Original, Disposable, package of 6 pcs, || GE Healthcare Finland Oy || Made in US || Rx Only || The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA