Events

Recall of FAST Procedure Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Optisurgical 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
    65098
  • Event Risk Class
    Class 2
  • Event Number
    Z-1505-2013
  • Event Initiated Date
    2013-04-30
  • Event Date Posted
    2013-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117880
  • 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
    Skin prep tray (kit) - Product Code OJU
  • Reason
    American optisurgical, inc initiated a recall of chloraprep hi-lite orange 3ml applicator, in response to a sub-recall letter from medline industries, inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
  • Action
    American Optisurgical Inc. sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL AND PRODUCT EXCHANGE" letter dated May 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-580-1266 for questions regarding this notice.

Device

FAST Procedure Kit
  • Model / Serial
    Lot Numbers 07912-06 12912-04
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.
  • Product Description
    FAST Procedure Kit. || Intended for use as a Minor Surgical Procedures Tray.
  • Manufacturer
    American Optisurgical Inc

Manufacturer

American Optisurgical Inc
  • Manufacturer Address
    American Optisurgical Inc, 26902 Vista Ter, Lake Forest CA 92630-8123
  • Source
    USFDA