Events

Recall of Right Heart Catheter Product Line: || Catalog Number 604025------------T046-02 0426D1009I RMM.

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
    32177
  • Event Risk Class
    Class 2
  • Event Number
    Z-1003-05
  • Event Initiated Date
    2005-05-25
  • Event Date Posted
    2005-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40235
  • 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
    Catheter, Flow Directed - Product Code DYG
  • Reason
    Reports in a small percentage of right heart catheter products line related to cracked catheter tips, leaking at the manifold and cracked hubs.
  • Action
    The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.

Device

Right Heart Catheter Product Line: || Catalog Number 604025------------T046-02 0426D1009I RMM.
  • Model / Serial
    Catalog Number 604025. Lot Number, Exp. Date: 0060575999, 4/30/06; 0060581062, 5/31/06; 0060717194, 8/31/06; 0060725153, 9/30/06; 0060730984, 10/31/06; 0060733271, 11/30/06.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
  • Product Description
    Right Heart Catheter Product Line: || Catalog Number 604025------------T046-02 0426D1009I RMM.
  • 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