Events

Recall of Device Recall Infusomat(R) Space Pump

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
    62115
  • Event Risk Class
    Class 1
  • Event Number
    Z-1992-2012
  • Event Initiated Date
    2012-03-23
  • Event Date Posted
    2012-07-16
  • 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=109869
  • 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
    Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the iv set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. if the clip catch is broken and the door opened, free flow protection is still ensured. however, after the set is manually removed from the pump without the closure of t.
  • Action
    B. Braun Medical, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify the affected product in their inventory and to complete and return the Product Acknowledgement Form via fax to (610)849-1197. Contact the Customer Support Department at (800) 626-7867 for assistance with returning any product or if you have questions regarding this notice.

Device

Device Recall Infusomat(R) Space Pump
  • Model / Serial
    Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
  • Product Description
    Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. || Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
  • 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