Events

Recall of Device Recall Sterile IV Start Kit

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
    75291
  • Event Risk Class
    Class 2
  • Event Number
    Z-0691-2017
  • Event Initiated Date
    2016-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149990
  • 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. start kit - Product Code LRS
  • Reason
    Positive results from non-routine sterility testing commissioned by b. braun medical inc. (bbmi) for the finished product of this lot.
  • Action
    BBMI (B. Braun) provided written notification on August 05, 2016, to all BBMI customers in receipt of the suspected product. These customers included both BBMI direct end customers and BBMI direct distributors. Customers were asked to determine if they had the affected lots in their possession. If they did, customers were asked not to destroy the product and to immediately discontinue use of and quarantine if found. Customers were also asked to complete the Product Removal Acknowledgement form and return to B. Braun. B. Braun will contact each customer if they have any full cases, partial cases or unused pieces of the affected products to provide instructions for handling and return of the affected products. Customers with questions were instructed to call 1-800-227-2862.

Device

Device Recall Sterile IV Start Kit
  • Model / Serial
    Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to GA, IL, and FL
  • Product Description
    Sterile IV Start Kits || 50 units/trays per case || Convenience kit for IV start procedures
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Manufacturer Address
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA