Events

Recall of Device Recall B. Braun Infusomat Space Pump US Version

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
    60995
  • Event Risk Class
    Class 1
  • Event Number
    Z-1015-2012
  • Event Initiated Date
    2011-07-12
  • Event Date Posted
    2012-02-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107007
  • 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
    Pump, Infusion - Product Code FRN
  • Reason
    If the iv set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed, the clip catch on the inside of the pump door may break. if the clip catch is broken and the door opened, free flow protection is ensured. if iv set is then removed from pump without closing the roller clamp, the clip may not re-engage the tubing, leaving an open fluid path with free flow pote.
  • Action
    B Braun sent a letter on August 16, 2011, to their customers, that detailed the proposed G03 implementation in response to reported customer complaints. The software upgrade with the door jam was agreed upon and the eight hospitals were upgraded in November 2011.

Device

Device Recall B. Braun Infusomat Space Pump US Version

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