Events

Recall of DocUDose

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eatonform 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
    36103
  • Event Risk Class
    Class 2
  • Event Number
    Z-0045-2007
  • Event Initiated Date
    2006-08-02
  • Event Date Posted
    2006-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47976
  • 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
    Medication reminder - Product Code NXQ
  • Reason
    Certain lots of packet components of the firm's doc-u-dose prescription management system are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.
  • Action
    The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 8/2/2006, 8/4/2006, and 8/11/2006. In their recall notifications, the firm requested that the pharmacy customers: 1) cease using and distributing all Doc-U-Dose packets identified with the recalled lot numbers; 2) segregate and secure all Doc-U-Dose packets identified with the suspect lot numbers on-hand; 3) inform the firm as to whether or not they have any of the suspect product which they would be returning and the quantity of product to be returned; 4) return all packets to Eatonform at the recalling firm¿s expense; and 5) notify their subaccount customers and ask that they cease using the device until such time as the problem is corrected.

Device

DocUDose
  • Model / Serial
    Four (4) lot codes are subject to recall: 312733, 312734, 313767, and 313768. This accounts for all of the Doc-U-Dose packets distributed by the firm since May 13, 2006.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime.''
  • Manufacturer
    Eatonform Inc

Manufacturer

Eatonform Inc
  • Manufacturer Address
    Eatonform Inc, 2280 Arbor Blvd, Dayton OH 45439-1522
  • Source
    USFDA