Events

Recall of Device Recall Beaver Visitec International, Inc

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
    71293
  • Event Risk Class
    Class 2
  • Event Number
    Z-1803-2015
  • Event Initiated Date
    2015-05-01
  • Event Date Posted
    2015-06-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137341
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Reason
    Devon light glove in procedure kits may have holes/slits compromising sterility of the product.
  • Action
    Beaver-Visitec International Sales Ltd. (BVI) sent an Urgent Field Safety Notice dated May 2, 2015, to all affected customers. Customers were instructed to quarantine the affected kits and return to BVI for subsequent replacement of product. A Verification Form was provided to confirm receipt of the recall notice. For questions regarding this recall call 791-906-7950.

Device

Device Recall Beaver Visitec International, Inc
  • Model / Serial
    Lot Numbers:  3038787 3046210 3061080 3078492 3093681 3095940 3108668
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including KY, GA, MI, and NJ.
  • Product Description
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove || Part Number: 584648 || Ophthalmic surgical kits
  • 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