Events

Recall of Device Recall Stericover

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

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
    35508
  • Event Risk Class
    Class 2
  • Event Number
    Z-1154-06
  • Event Initiated Date
    2006-05-15
  • Event Date Posted
    2006-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46283
  • 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
    Drape, polyethylene - Product Code KKX
  • Reason
    Non-sterility-distributor testing of outside manufacturer's product (sterimed, inc) revealed positive sterility test results.
  • Action
    Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction

Device

Device Recall Stericover
  • Model / Serial
    Lot #s: 0796316, 0796319 and 0796320.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NATIONWIDE-Drapes consigned to sales agents located in CA, FL, IL, MD, MI, OK, OH, TX, and WI.
  • Product Description
    Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.
  • Manufacturer
    Abbott Spine

Manufacturer

Abbott Spine
  • Manufacturer Address
    Abbott Spine, 12708 Riata Vista Cir # B-100, Austin TX 78727-7167
  • Source
    USFDA