Events

Recall of Device Recall B. Braun addEASE Binary Connector

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
    56164
  • Event Risk Class
    Class 1
  • Event Number
    Z-0306-2011
  • Event Initiated Date
    2010-06-24
  • Event Date Posted
    2010-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92791
  • 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
    I.V. Fluid Transfer Set - Product Code LHI
  • Reason
    During this insertion, fragmentation of the pab container stopper may occur resulting in a small amount of visible particulates in the solution.
  • Action
    On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached "Product Removal Acknowledgement" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. If consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at (800) 227-2862 to arrange for return. Canadian customers may call (800) 624-2920. International customers may call (610) 691-5400. A Customer Support Representative will provide consignees with instructions for handling the affected product. The firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the consignees facility. Consignees were informed that B. Braun is currently working to resolve this issue and provide an acceptable alternative to the market. They expect this product to be available in August 2010. In the interim, B. Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use. If customers have additional questions regarding with a matter, they are to call B. Braun Customer Support Department at the number listed above. Should consignees identify product where this condition has occurred, consignees were asked to report it promptly to B. Braun Medical Inc. by contacting the B. Braun Clinical and Technical support at 1-800-854-6851.

Device

Device Recall B. Braun addEASE Binary Connector
  • Model / Serial
    Lot Numbers:  60928513, 60936541, 60936543, 60942059, 60950900, 60953588, 60969534, 60972173, 60973280, 60983742, 60997643, 61003958, 61017469, 61027183, 61027186, 61031167, 61031168, 61042196, 61045157, 61056656, 61057867, 61058745, 61073202, 61078826, 61085625, 61096650, 61102775, 00VL907673, 00VL907677, 00VL912573, 00VL927133, 00VL927134, and 00VL927135.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box) || Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
  • Manufacturer
    B. Braun Medical Inc

Manufacturer

B. Braun Medical Inc
  • Manufacturer Address
    B. Braun Medical Inc, 2525 McGaw Ave, Irvine CA 92614-5841
  • Source
    USFDA