Events

Recall of Device Recall Premier Edge MVR 20g Microsurgical 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
    38130
  • Event Risk Class
    Class 2
  • Event Number
    Z-0997-2007
  • Event Initiated Date
    2007-06-08
  • Event Date Posted
    2007-07-04
  • 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=53009
  • 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
    Microsurgical Knife - Product Code HNN
  • Reason
    This voluntary recall has been initiated due to the product puncturing the packing during rough handling. once the packaging is damaged, the product is no longer sterile as labeled.
  • Action
    Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."

Device

Device Recall Premier Edge MVR 20g Microsurgical Knife, Angled
  • Model / Serial
    Lot #'s DK0107Y, DK0307D, DK0307Q, DK1206M
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.
  • Product Description
    Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Manufacturer Address
    Oasis Medical Inc, 510-528 South Vermont Ave, Glendora CA 91741
  • Source
    USFDA