Events

Recall of Device Recall Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike

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
    46348
  • Event Risk Class
    Class 3
  • Event Number
    Z-1035-2008
  • Event Initiated Date
    2007-12-10
  • Event Date Posted
    2008-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67219
  • 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
    Hemodialysis kit - Product Code FJK
  • Reason
    Faulty tubing does not prime machine as intended.
  • Action
    B. Braun Medical sent an Urgent Medical Device Reall letter dated 12/12/07. Customers were told to discontinue use of the tubing.

Device

Device Recall Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike
  • Model / Serial
    Lot Number 07F06 exp 2012-05 and Lot Number 07G09 exp 2012-06
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109
  • 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