Events

Recall of Device Recall AVID Medical QA Pack

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
    79135
  • Event Risk Class
    Class 2
  • Event Number
    Z-0581-2018
  • Event Initiated Date
    2017-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161426
  • 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
    The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
  • Action
    Avid Medical began shipping this product on 05/23/2017. Immediately examine your inventory and quarantine all product subject to this correction. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Correction notice. Please complete the attached Correction Response Form as soon as possible. Attached is a label template for use in the generation of an appropriate warning label for application on all AV10654-10 inventory of impacted lot 1235229. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user location information request to sharon.moll@owens-minor.com. Replacement component swab stick collection systems are available upon request. This correction will be executed with oversight of the associated account sales rep. Please complete and return the enclosed response form as soon as possible.

Device

Device Recall AVID Medical QA Pack
  • Model / Serial
    Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.
  • Product Description
    AVID Medical QA Pack AV10654-10
  • Manufacturer
    Avid Medical, Inc.

Manufacturer

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