Events

Recall of B. Braun HyperFormer Pump Dispensing 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
    37855
  • Event Risk Class
    Class 2
  • Event Number
    Z-0783-2007
  • Event Initiated Date
    2007-04-11
  • Event Date Posted
    2007-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51960
  • 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
    HyperFormer Pump Dispensing Set, - Product Code LHI
  • Reason
    The integrity of the sterile product barrier may be compromised.
  • Action
    An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.

Device

B. Braun HyperFormer Pump Dispensing Set
  • Model / Serial
    Lot number 0060911602
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution --- including states of GA, MA, OH, and TX
  • Product Description
    B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

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