Events

Recall of Device Recall Healon GV

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

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
    28002
  • Event Risk Class
    Class 3
  • Event Number
    Z-0346-04
  • Event Initiated Date
    2003-12-11
  • Event Date Posted
    2004-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30988
  • 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 product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
  • Action
    The firm contacted their consignees on 12/11/2003 by telephone and letter.

Device

Device Recall Healon GV
  • Model / Serial
    Lots: #5047293 and #5048892
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to customers in OH and PA.
  • Product Description
    Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 6540 Port Rd, Groveport OH 43125-9103
  • Source
    USFDA