Events

Recall of Device Recall Hologic ATEC Canister

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, 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
    74295
  • Event Risk Class
    Class 2
  • Event Number
    Z-2239-2016
  • Event Initiated Date
    2016-05-31
  • Event Date Posted
    2016-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147096
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Reason
    Cracks atec canister lids.
  • Action
    Customers were notified of the recall via certified letter beginning on May 31, 2016. The letter requests that customers immediately inventory your supplies of the Recalled product in all appropriate areas and cease use of all affected stock. In addition, they are asked to complete the enclosed Recall Response Card indicating whether you have any of the Recalled product on hand, as well as the quantity of product that you have in stock.

Device

Device Recall Hologic ATEC Canister
  • Model / Serial
    Lot Number: 20150013 and 20150014
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: United Arab Emirates, Australia, Argentina, Belgium, Canada, Switzerland, Chile, Colombia, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Qatar, Singapore, Thailand, Taiwan, and South Africa.
  • Product Description
    ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
  • Manufacturer
    Hologic, Inc

Manufacturer

Hologic, Inc
  • Manufacturer Address
    Hologic, Inc, 250 Campus Dr, Marlborough MA 01752-3020
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA