Events

Recall of Device Recall Baxter BURETROL Solution 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
    68843
  • Event Risk Class
    Class 2
  • Event Number
    Z-2614-2014
  • Event Initiated Date
    2014-07-14
  • Event Date Posted
    2014-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128841
  • 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
    Baxter healthcare corporation is voluntarily issuing a recall for specific lots of buretrol solution set product codes due to complaints for separation between the burette chamber and the drip chamber. affected product codes are: 2c7564, 2c8864 and 2h8864.
  • Action
    Action to be taken if product was purchased directly from Baxter: Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail. 4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014. Action to be taken if the products were purshased from a distributor or re-seller. 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.

Device

Device Recall Baxter BURETROL Solution Set
  • Model / Serial
    2C8864- Buretrol Solution Set with 150mL CLEARLINK Burette, lots:  DR13E08015 DR13E08023 DR13E09013 DR13I26027 DR13I27017 DR13I27025 DR13I28015 DR13I28023 DR13J16027 DR13J17025 DR13J28022 DR13J29020 DR13K01019 DR13K20027 DR13K21025 DR13L19019 DR13L19027 DR14A11017 DR14A14011 DR14A24010 DR14A24036 DR14A31049 DR14B07054 DR14B22012 DR14B28050 DR14C01030 DR14C06013 DR14C06039
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    ***Baxter***BURETROL Solution Set***105" (2.7 m) || 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic. || ****Indications for Use: For the administration of fluids || from a container into the patient's vascular system || through a vascular access device.***
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • Manufacturer Address
    Baxter Healthcare Corp, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA