Events

Recall of Device Recall PremierEdge MICROSURGICAL KNIFE 2.0mm Angled Crescent Tunnel Knife, Angled

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oasis Medical 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
    45870
  • Event Risk Class
    Class 2
  • Event Number
    Z-0506-2008
  • Event Initiated Date
    2007-07-18
  • Event Date Posted
    2008-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66360
  • 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
    Ophthalmic Knife - Product Code HNN
  • Reason
    Sterility (package integrity) compromised: the device is puncturing the packing during handling. once the packaging is damaged, the product is no longer sterile as labeled. this is an expansion of a previous recall.
  • Action
    A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.

Device

Device Recall PremierEdge MICROSURGICAL KNIFE 2.0mm Angled Crescent Tunnel Knife, Angled
  • Model / Serial
    Lot No: DK0107AA, DK0207H, DK0207AD and DK0307E
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia
  • Product Description
    PremierEdge MICROSURGICAL KNIFE,2.0mm Angled Crescent Tunnel Knife, Angled, Item Code/REF: PE 3720A; OASIS Glendora, CA 91741
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Manufacturer Address
    Oasis Medical Inc, 514 S Vermont Ave Bldg 510-528, Glendora CA 91741-6205
  • Manufacturer Parent Company (2017)
    Oasis Medical Inc.
  • Source
    USFDA