Recall of Device Recall Baxter Extension Sets with PosiFlow Access Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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, Administration, Intravascular - Product Code FPA
  • Reason
    Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
  • Action
    Urgent Device Correction letters dated 3/3/05 were sent to the direct accounts via first class mail, to the attention of the Director of Nursing. The accounts were informed of the field reports received concerning the PosiFlow Access Device and IV sets containing the PosiFlow device and the changes made to the directions for use and in-service training materials to correct the problems. The accounts were requested to complete and fax back to Baxter at 847-270-5457 the enclosed customer reply form, acknowledging the receipt and dissemination of the information to their staff. Wholesalers were requested to notify their customers. Any questions were directed to the Center for One Baxter at 1-800-422-9837.


  • Model / Serial
    product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; all lots
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    Baxter Extension Sets with PosiFlow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with PosiFlow Positive Displacement Feature; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the PosiFlow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson
  • Manufacturer


  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source