Events

Recall of AVID TruCustom

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Avid 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
    73465
  • Event Risk Class
    Class 2
  • Event Number
    Z-2589-2016
  • Event Initiated Date
    2015-10-05
  • Event Date Posted
    2016-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144242
  • 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
    General surgery tray - Product Code LRO
  • Reason
    Avid medical inc. states a latex-containing telfa" non-adherent dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
  • Action
    Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 cm) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.

Device

AVID TruCustom
  • Model / Serial
    Catalog No. MCVA0089-04 , LOT# 1010997
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Recalled product was distributed to 2 states: Virginia and Massachusetts.
  • Product Description
    Convenience Kits, MOHS "OPENING" || PROCEDURE TRAY
  • Manufacturer
    Avid Medical, Inc.

Manufacturer

Avid Medical, Inc.
  • Manufacturer Address
    Avid Medical, Inc., 9000 Westmont Dr, Toano VA 23168-9351
  • Source
    USFDA