Events

Recall of DStat Dry Hemostatic Bandage

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B. Braun 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
    33598
  • Event Risk Class
    Class 2
  • Event Number
    Z-0003-06
  • Event Initiated Date
    2005-09-15
  • Event Date Posted
    2005-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42138
  • 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
    Dressing, Wound, Drug - Product Code FRO
  • Reason
    Package sealing defect - product may not be sterile.
  • Action
    The recalling firm issued a recall letter dated 9/15/05 informing their accounts of the problem and the need to return the product.

Device

DStat Dry Hemostatic Bandage
  • Model / Serial
    Lot numbers 301323A and 301393
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals/medical facilities in AZ, CA, FL, GA, IL, MA, MN, MO, NY, NJ, OH, PA, TN, TX, and WI.
  • Product Description
    D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Manufacturer Address
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA