Events

Recall of CytoGuard Closed Luer Connector

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
    77112
  • Event Risk Class
    Class 2
  • Event Number
    Z-2155-2017
  • Event Initiated Date
    2017-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155027
  • 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
    B. braun is voluntarily recalling 13 lots of cytoguard closed luer connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
  • Action
    B. Braun mailed an Urgent Medical Device Recall Notice to affected customers to inform them of the issue. Customers were asked to determine their current inventory and to not destroy any of the product; however, product should be discontinued immediately and quarantined and return the acknowledgement form for product return.

Device

CytoGuard Closed Luer Connector
  • Model / Serial
    Lot #  1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States Nationwide distribution
  • Product Description
    CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
  • Manufacturer
    B Braun Medical Inc

Manufacturer

B Braun Medical Inc
  • Manufacturer Address
    B Braun Medical Inc, 200 Boulder Dr, Breinigsville PA 18031-1532
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA