Events

Recall of ATEC BREAST BIOPSY & EXCISION SYSTEM (PEARL) - SUCTION CANISTER

According to Health Canada (via FOI), this recall involved a device in Canada 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
    44102
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Hologic is recalling certain lots of its atec canister because the canister lid may have cracks. the lot numbers affected by the recall are as follows: lot # 20150013 and 20150014.

Device

ATEC BREAST BIOPSY & EXCISION SYSTEM (PEARL) - SUCTION CANISTER
  • Model / Serial
    Model Catalog: ATEC SUCTION CANISTER (Lot serial: Lot # 20150013); Model Catalog: ATEC SUCTION CANISTER (Lot serial: Lot # 20150014)
  • Product Description
    ATEC Canister
  • Manufacturer
    HOLOGIC INC.

Manufacturer

HOLOGIC INC.
  • Manufacturer Address
    MARLBOROUGH
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC