Events

Recall of Device Recall Baxter Continuous Epidural Anesthesia Trays

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
    34381
  • Event Risk Class
    Class 2
  • Event Number
    Z-0507-06
  • Event Initiated Date
    2006-01-10
  • Event Date Posted
    2006-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43706
  • 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
    Anesthesia Conduction Kit - Product Code CAZ
  • Reason
    The bd catheter connector contained in the epidural anesthesia trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
  • Action
    Baxter sent Urgent Product Recall letters dated 1/10/06 to their customers, to the attention of the Director of Anesthesia, via first class mail on the same date. The accounts were informed that the BD catheter connector in the tray may not fully secure the catheter, resulting in the possible leakage or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and destroy it for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Continuous Epidural Anesthesia Trays
  • Model / Serial
    product code 1T1571, lot GD822999;  product code 1T1672, lot GD822908;  product code 1T2574, lot GD822791;  product code1T2673, lot GD822619;  product code 1T5681, lot GD822536
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Baxter Continuous Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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