Events

Recall of Baxter Lock Box for 100 mL or 250 mL Bag Set

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
    29958
  • Event Risk Class
    Class 2
  • Event Number
    Z-1569-05
  • Event Initiated Date
    2004-09-01
  • Event Date Posted
    2005-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34844
  • 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
    Pump, Infusion - Product Code FRN
  • Reason
    The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. the pump will alarm 'door open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.
  • Action
    Urgent Device Correction letters dated 9/1/04 were sent to all U.S. Baxter affected customers on the same date, to the attention of the Director of Nursing. The facilities were advised of the free-flow incident and as a result that Baxter wanted to heighten awareness of the proper clinical procedures for loading the sets into the infusion systems using these Lock Boxes with the 6060 Multi-Therapy Pump. Baxter''s investigation into the event confirmed that the 6060 pump door was left open after the lock box was attached to the pump. Baxter provided copie of the instructions for use of the lock box and pages from the 6060 pump operator''s manual which outline the proper procedure for loading the sets into the the pump and the pump into the lock box. The accounts were requested to complete and fax back to Baxter the enclosed response form, erifying receipt of the letter, confirming that the information has been provided to all users of the infusion system, and allowing Baxter to order and ship labels for the lock box and revised instructions for use to the facility. Any questions were directed to 1-800-843-78867.

Device

Baxter Lock Box for 100 mL or 250 mL Bag Set
  • Model / Serial
    all lot numbers/serial numbers of product codes 2L9354 and 606194
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Australia, Belgium, Canada, France, Hong Kong, Portugal, Spain and the United Kingdom.
  • Product Description
    Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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