Events

Recall of Device Recall OASIS Medical SOFT PLUG

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
    36277
  • Event Risk Class
    Class 3
  • Event Number
    Z-1520-06
  • Event Initiated Date
    2006-07-06
  • Event Date Posted
    2006-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48317
  • 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
    Medical plug - Product Code LZU
  • Reason
    Labeled with an incorrect diameter.
  • Action
    OASIS¿ Medical informed all customers via FAX and Certified Mailt that received the product that the firm was voluntarily recalling one lot of the SOFT PLUG¿ Extended Duration Plugs (REF 6403) and to cease use immediately. Customers are advised to check their inventory and return any remaining and return all unused product to OASIS¿ Medical SOFT PLUG¿ Extended Duration Plugs (REF 6403) from Lot LA1105E by FedEx. Customers are also advised that if they have used the product, to inform OASIS Medical of the number of samples of this lot used for an accurate account of the product distributed, used and returned.

Device

Device Recall OASIS Medical SOFT PLUG
  • Model / Serial
    Lot LA1105E
  • Product Classification
    Ophthalmic Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ----USA and countries of Chile, and United Kingdom.
  • Product Description
    OASIS¿ Medical SOFT PLUG¿ Extended Duration Plug, Reference 6403 (Lot LA1105E)
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Manufacturer Address
    Oasis Medical Inc, 512 S Vermont Ave, Glendora CA 91741-6205
  • Source
    USFDA