Events

Recall of Device Recall CapsLock Cannula

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

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
    32688
  • Event Risk Class
    Class 2
  • Event Number
    Z-1043-05
  • Event Initiated Date
    2005-07-12
  • Event Date Posted
    2005-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40566
  • 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, Surgical, General & Plastic Surgery - Product Code GEA
  • Reason
    Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection.
  • Action
    The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation.

Device

Device Recall CapsLock Cannula
  • Model / Serial
    Lot Numbers: 1905, 1904
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to 19 consignees in foreign countries, including Denmark, Spain, Lebanon, Finland, Saudi Arabia, the UK, Egypt, Italy, and Australia, as well as 12 medical facilities in New Jersey, New York, Ohio, Maryland, Montana, Oregon, Illinois, Washington, Wisconsin and Nevada. Dates of distribution and manufacture are approximations, provided by the recalling firm.
  • Product Description
    ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.
  • Manufacturer
    ArthroCare Corporation

Manufacturer

ArthroCare Corporation
  • Manufacturer Address
    ArthroCare Corporation, 680 Vaqueros Ave, Sunnyvale CA 94085-3523
  • Source
    USFDA