Events

Recall of Device Recall IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin

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
    51869
  • Event Risk Class
    Class 2
  • Event Number
    Z-1427-2009
  • Event Initiated Date
    2009-03-27
  • Event Date Posted
    2009-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81478
  • 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
    Intravascular administration set - Product Code FPA
  • Reason
    Device defect is occlusion/no flow.
  • Action
    An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.

Device

Device Recall IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backche...
  • Model / Serial
    Catalog #352049 - Lot #'s 61028761, 61028762, 61028763, 61028764, 61028765, 61028766, 61028767, 61028769, 61028771, and 61028772 all with an expiration date of 1/31/2014.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. || For use with Secondary Container.
  • 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