Events

Recall of Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible 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
    34598
  • Event Risk Class
    Class 2
  • Event Number
    Z-0586-06
  • Event Initiated Date
    2006-02-06
  • Event Date Posted
    2006-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44161
  • 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
    Container, I.V. - Product Code KPE
  • Reason
    B. braun medical has been notified by the manufacturer of the product (stedim) that a small percentage of the lots leak from the set port when the set port is opened. the leak was identified by stedim to be due to the incorrect placement of a septum in the set port. the set closure is intact and the leak remains internal until the set port is opened.
  • Action
    A recall notification letter was sent to the 22 customers who received the product between 12/1/05 and 1/11/06. The recall packages included a letter addressed to either the Director of Pharmacy/Director of Nursing, Materials Manager, or Distributor, as appropriate. They were mailed via US Post Office certified return receipt mail. Customers were instructed by letter to return all product at their facility to B. Braun Medical, Inc. in Breinigsville Pennsylvania. A Recall Information Form and a postage paid B. Braun Medical, Inc. return envelope were included in the recall package for the customer''s use.

Device

Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector
  • Model / Serial
    Lot Numbers: 05A14474, 05A18561, & 05A19926
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to: CA, CT, FL, GA, KS, MD, MI, NC, NJ, NY, SC, TN, & TX
  • Product Description
    B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926
  • Manufacturer
    B. Braun Medical Inc

Manufacturer

B. Braun Medical Inc
  • Manufacturer Address
    B. Braun Medical Inc, 2525 McGaw Ave, Irvine CA 92614-5841
  • Source
    USFDA