Events

Recall of Device Recall Eagle Labs Corneal Marking Pad, Sterile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aspen Surgical Products, 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
    57792
  • Event Risk Class
    Class 2
  • Event Number
    Z-1337-2011
  • Event Initiated Date
    2010-12-23
  • Event Date Posted
    2011-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97450
  • 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
    Corneal Marking Pad - Product Code HMR
  • Reason
    Fragments from the pad may disengage and stick to the instrument. the condition could cause fragments to come into contact with the intact cornea prior to surgery.
  • Action
    Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers. The firm does not intend to continue manufacturing or distributing the product.

Device

Device Recall Eagle Labs Corneal Marking Pad, Sterile
  • Model / Serial
    2010-12-09, 2013-02-23, 2013-08-12, 2013-09-24.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
  • Product Description
    Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
  • Manufacturer
    Aspen Surgical Products, Inc.

Manufacturer

Aspen Surgical Products, Inc.
  • Manufacturer Address
    Aspen Surgical Products, Inc., 6945 Southbelt Dr Se, Caledonia MI 49316-7664
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA