Events

Recall of Device Recall Baxter PosiFlow Access Device for IV Access

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
    Recall
  • Event ID
    31275
  • Event Risk Class
    Class 2
  • Event Number
    Z-0853-05
  • Event Initiated Date
    2005-03-03
  • Event Date Posted
    2005-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37579
  • 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.

Device

Device Recall Baxter PosiFlow Access Device for IV Access
  • Model / Serial
    product code 2N9050, all lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the PosiFlow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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