Events

Recall of Device Recall B. Braun Stopcock Extension Set

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
    68546
  • Event Risk Class
    Class 2
  • Event Number
    Z-2022-2014
  • Event Initiated Date
    2014-05-29
  • Event Date Posted
    2014-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128169
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Complaints were received that reported the stopcock of some stopcock extension sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.
  • Action
    An urgent medical device correction notification, dated June 3, 2014, describing the product, problem, and actions to be taken, was sent to end users and distributors.

Device

Device Recall B. Braun Stopcock Extension Set
  • Model / Serial
    Product codes: 473547 and 473549  lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and  61367665, 3/31/2019.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.
  • Product Description
    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
  • 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