Events

Recall of Device Recall Visitec Anterior Chamber Cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beaver-Visitec International 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
    68281
  • Event Risk Class
    Class 2
  • Event Number
    Z-1664-2014
  • Event Initiated Date
    2014-05-06
  • Event Date Posted
    2014-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127265
  • 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, ophthalmic - Product Code HMX
  • Reason
    Contains a sharp tip needle when the product should contain a blunt tip cannula.
  • Action
    Beaver Visitec (BVI) sent a Product Recall Notice dated May 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return any un-opened product of the affected lot so that BVI can replace the product or issue credit to their company. Customers were asked to fax or email the customer response form to 866-906-4304 or claimsUS@beaver-visitec.com as acknowledgement of the letter. Customers with questions should call 781-906-7986. For questions regarding this recall call 781-906-7950.

Device

Device Recall Visitec Anterior Chamber Cannula
  • Model / Serial
    Lot number: 3079324
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.
  • Product Description
    Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) || REF 585006 || Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth
  • Manufacturer
    Beaver-Visitec International Inc.

Manufacturer

Beaver-Visitec International Inc.
  • Manufacturer Address
    Beaver-Visitec International Inc., 411 Waverley Oaks Rd Ste 229, Waltham MA 02452-8422
  • Manufacturer Parent Company (2017)
    Tpg Capital Management L.P.
  • Source
    USFDA