Events

Recall of Device Recall Dressing Rect L

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Breg 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
    76994
  • Event Risk Class
    Class 2
  • Event Number
    Z-1903-2017
  • Event Initiated Date
    2017-03-30
  • Event Date Posted
    2017-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154790
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Reason
    They may not have been sealed prior to sterilization. products with unsealed pouches will be non-sterile.
  • Action
    Breg sent an Urgent Medical Device Correction Letter to customers on 4/13/17. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: Please take the following actions: 1) Determine if any potentially affected products are in your stock by comparing each product's Lot and Date to the Lot Numbers and Expiration Dates in the table above. Refer to Picture 2 for the location of these fields on the product packaging. 2) Once you have matched Lot and Date, inspect the product to identify any open (unsealed) pouches. Refer to Picture 1 below. 3) Remove any open pouches from your inventory and discard. 4) Complete the Response Form included as Attachment A, and email or fax to Breg as follows: a. E-mail: bregfieldcorrection@breg.com: Subject: Sterile Dressing Correction b. Fax: 800-FAX-BREG (329-2734)- Subject: Sterile Dressing Correction Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607.

Device

Device Recall Dressing Rect L
  • Model / Serial
    D163474, D163544
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Dressing Rect L, P/N 02428 || Product Usage: || These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
  • Manufacturer
    Breg Inc

Manufacturer

Breg Inc