Events

Recall of Device Recall 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
    79162
  • Event Risk Class
    Class 2
  • Event Number
    Z-0797-2018
  • Event Initiated Date
    2017-06-22
  • 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=161493
  • 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
    Certain kits packed by the firm contain bd 22ga 1-1/2 inch safetyglide non sterile bulk needles that may contain loose polypropylene foreign material above the release specification.
  • Action
    An email notification was sent to all sales representatives with the BD recall notification and the following instructions: " Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. " All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited. " Label Quantity- 1 for each affected tray, plus 1 for each outside carton. " Contact Name " Address " Phone Number Sales representatives were asked to confirm to QualityAssurance@owens-minor.com that your customers were notified.

Device

Device Recall AVID TruCustom
  • Model / Serial
    Lot, Expiration Date: 1211878, 7/1/2018
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
  • Product Description
    AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
  • Manufacturer
    Avid Medical, Inc.

Manufacturer

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