Events

Recall of B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000

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
    65356
  • Event Risk Class
    Class 2
  • Event Number
    Z-0425-2014
  • Event Initiated Date
    2013-04-04
  • Event Date Posted
    2013-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118621
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • Reason
    Possible solution leakage at the interface of the addease(tm) binary connector (product codes bc2000 and bc1300) and the pab(r) bag. based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addease(tm) binary connector, which pierces the pab(r) bag stopper to access the solution. the misaligned cannula may result i.
  • Action
    B Braun sent an Urgent - Medical Device Removal Notification letter dated April 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by he customer. Customers were instructed to review the Product Recall Notification in its entirety and ensure that all users in their organization are informed about this voluntary product recall. Determine their current inventory of the affected lots within their distribution center. Contact their customers that have received the affected lots and inform them of this voluntary product recall. Combine both their inventory, and the inventory reported by their customers, and utilize their specific "Product Removal Acknowledgement" form to record the total number of individual units (within partial cases) and the number of full-unopened cases. If no inventory remaining enter zero (0). Return the completed Acknowledgement Form to BBMI Quality Assurance in the self addressed envelope or fax to 610-849-1197. Customers should call Customer Support Department at 800-227-2862 to arrange for eturn and replacement product or for questions. For questions regarding this recall call 800-227-2862.

Device

B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000
  • Model / Serial
    Material BC1300, Lot number 61286479.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 || Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
  • 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