Events

Recall of Device Recall dynarex Specimen Containers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dynarex Corporation.

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
    73584
  • Event Risk Class
    Class 2
  • Event Number
    Z-2057-2016
  • Event Initiated Date
    2016-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144534
  • 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
    Container, specimen, non-sterile - Product Code NNI
  • Reason
    Exterior carton is mis-labeled as sterile. non-sterile, bulk specimen containers were packed in incorrect exterior carton.
  • Action
    On March 2, 2016, dynarex Corporate Headquarters distributed Voluntary Device Recall notices and Recall Verification Forms to their customers via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to examine their stock immediately to determine if they have any of the lots listed on hand. If so, discontinue distributing and quarantine the product immediately. Promptly contact the Dynarex Credit & Return representative Avi Celnick (845-365-8200 Ext 6644) to arrange for product return. Customers account will be credited for all returned products. All customers are advised to complete the Voluntary Recall Verification Form and returm immediately via fax or e-mail to Vijay Sachdev (Fax 845-365-8238; v.sachdev@dynarex.com).

Device

Device Recall dynarex Specimen Containers
  • Model / Serial
    Lot Numbers: 31899, 32014, 32015, 32410 & 32411
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
  • Product Description
    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only || Product Usage:containers for sample collection
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • Manufacturer Address
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962-1207
  • Manufacturer Parent Company (2017)
    Dynarex Corporation
  • Source
    USFDA