Events

Recall of Device Recall Steriseal BiManual Irrigating/Aspirating Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, 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
    70675
  • Event Risk Class
    Class 2
  • Event Number
    Z-1820-2015
  • Event Initiated Date
    2015-03-02
  • Event Date Posted
    2015-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134473
  • 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
    Cannula, ophthalmic - Product Code HMX
  • Reason
    The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
  • Action
    Customers were notified via telephone and e-mail by 03/02/2015. The firm is requiring customers to complete a submitted response form and certificate of destruction for recalled devices by 03/31/2015. If recalled devices were further distributed the firm is asking customers to conduct a sub recall and forward notice of the recall. Public contact is Aspen Medical Europe Ltd, QA Department, Lynda McConaghy-QARA Manager, Lynda.McConaghy@aspenmedicaleurope.com , or +44 (0)1527 587716.

Device

Device Recall Steriseal BiManual Irrigating/Aspirating Handpiece
  • Model / Serial
    Product #s: 157400; 257400; 157500; 257500
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.
  • Product Description
    Steriseal-Cannula Ophthalmic; || Bi-Manual Irrigating/Aspirating Handpiece.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA