Events

Recall of Disposable Bimanual Irrigation and Aspiration Handpiece Set

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
    38120
  • Event Risk Class
    Class 2
  • Event Number
    Z-0741-2007
  • Event Initiated Date
    2007-04-09
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53023
  • 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 irrigation and aspiration - Product Code KYG
  • Reason
    Plastic shavings are coming from the product handle during irrigation. use of this product may leave plastic shavings in the patient's eyes.
  • Action
    An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) 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 of this product recall. Your notification to your customers may be enhanced by induding 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

Disposable Bimanual Irrigation and Aspiration Handpiece Set
  • Model / Serial
    ltem #1720 Bimanual Irrigation/Aspiration Set 20 Gauge: DB0105B, DB0l06A, DB0605F, DB0705J, DB0705J, DB0804B, DB0804B, DB1005A, DB1104H, DB1104I; Item #1720-A Disposable Bimanual Aspiration Handpiece 20g: DB1004I; ltem # 1720-I Disposable Bimanual Irrigation Handpiece 20g: DB0105D, DB0305A, DB0305A, DB0705B, DB0705I, DB1004H; Item #1720-S Disp Bimanual l/A Set 20g Dual Port Smooth: DB0505B, DB0505B, DB0605G, DB0705K, DB1205C
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
  • Product Description
    Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge, Dual Port; Item #1720-A - Disposable Bimanual Aspiration Handpiece 20g; Item #1720-I Disposable Bimanuals Irrigation/Aspiration Set 20g, Open End; Item #1720-S Disposable Bimanuals Irrigation/Aspiration Set, 20g, Dual Port, Smooth. For use in cataract surgical procedures.
  • Manufacturer
    Oasis Medical Inc

Manufacturer

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