Events

Recall of Baxter Interlink System NonDHEP Extension 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
    56718
  • Event Risk Class
    Class 2
  • Event Number
    Z-0151-2011
  • Event Initiated Date
    2010-09-09
  • Event Date Posted
    2010-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94350
  • 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
    Stopcock, i.V. Set - Product Code FPA
  • Reason
    During packaging testing, baxter observed tears and pinholes in chevron-style pouches for certain infusion disposable products. the pinholes and tears could compromise the sterile barrier properties of the pouch.
  • Action
    Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Baxter Interlink System NonDHEP Extension Set
  • Model / Serial
    product 2N5602, lots UR171421, UR188847, UR216556, UR233510, UR239897, UR239962, UR240036, UR256172, UR262741, UR274365, UR288290, UR299370, UR320085, UR324343, UR08C11045, UR137315, UR143602, UR156497, UR164178, UR164798, U254078R, U256941R, U284562R, U332536R, U332643R, U468785R, U473728R, U480780R, U490003R, U493031R, U495069R, U497420R, U497826R, U497867R, U497941R, U510016R, U510115R, U530972R, U538090R, U546036R, U548107R, U560847R and U572503R
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
  • Product Description
    Baxter Interlink System Non-DHEP Extension Set; 8.3" (21.0 cm), Volume 1.4 mL, Large Bore 3-Way Stopcock with Rotating Male Luer Lock, Injection Site, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N5602 || For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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