Events

Recall of Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages

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
    29031
  • Event Risk Class
    Class 2
  • Event Number
    Z-0951-04
  • Event Initiated Date
    2004-05-10
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33001
  • 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
    Bandage, Elastic - Product Code FQM
  • Reason
    Bandages labeled as "100% latex free" may contain latex. the wrapper was analytically tested by a private laboratory and found to contain latex.
  • Action
    Recall letters & response forms were sent to the consignees on 5/10/04 via Certified Mail, Return Receipt Requested. On 5/24/04, a second recall letter & response form were mailed via Certified Mail to the 60 distributors that received the 2 additional lots being recalled.

Device

Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages
  • Model / Serial
    Lot 15860 (recall letter 5/07/04). UPDATE: Lots 15901 & 15706 (recall letter 5/20/04)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Medical supply distributors located in NY, NJ, PA, TX, MN, GA, FL, MI, OH, IL, MS, KY, AZ , CA, NV, CO, and Puerto Rico, for further distribution to their customers. --- UPDATE: There were 2 foreign accounts in Panama that received the additional lots. The additional lots were distributed to the aforementioned states plus the following states: MA, MO, ME, VA, NC, LA.
  • Product Description
    100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- || Device Listing # E177598. 510(k) Exempt.
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • Manufacturer Address
    Dynarex Corporation, 10 Glenshaw Street, Orangeburg NY 10962-1207
  • Source
    USFDA