Events

Recall of ACMI

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

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
    28975
  • Event Risk Class
    Class 2
  • Event Number
    Z-0928-04
  • Event Initiated Date
    2004-04-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32897
  • 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
    Lithotriptor, Electro-Hydraulic - Product Code FFK
  • Reason
    Product sterility may be compromised due to the lack of package seal integrity.
  • Action
    ACMI issued a recall letter dated 4/30/04 via Certified Mail. Users will be asked to return unused product. International Distributors were faxed letters notifying of them of the action.

Device

ACMI
  • Model / Serial
    Lot Numbers: 115823D to 1283724C
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey
  • Product Description
    ACMI REF E-9F Electrohydraulic Lithotripsy Probe, || 9 FR x 60CM
  • Manufacturer
    ACMI CORPORATION

Manufacturer

ACMI CORPORATION
  • Manufacturer Address
    ACMI CORPORATION, 136 Turnpike Road, Southborough MA 01772
  • Source
    USFDA