Events

Recall of Device Recall CustomPak Surgical Packs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Laboratories, 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
    37153
  • Event Risk Class
    Class 2
  • Event Number
    Z-0563-2007
  • Event Initiated Date
    2006-12-22
  • Event Date Posted
    2007-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50435
  • 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
    Surgical Packs - Product Code HNN
  • Reason
    Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
  • Action
    Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level.

Device

Device Recall CustomPak Surgical Packs
  • Model / Serial
    Lot #633317H, 645074H, and 629784H.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
  • Product Description
    Alcon Custom-Pak¿, part #6515-51, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
  • Manufacturer
    Alcon Laboratories, Inc

Manufacturer

Alcon Laboratories, Inc
  • Manufacturer Address
    Alcon Laboratories, Inc, 9965 Buffalo Speedway, Houston TX 77054-1309
  • Source
    USFDA