Events

Recall of Device Recall Baxa Vial Adapter, 14mm Luer Lock

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxa Corporation.

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
    66082
  • Event Risk Class
    Class 2
  • Event Number
    Z-2165-2013
  • Event Initiated Date
    2013-08-22
  • Event Date Posted
    2013-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121455
  • 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, i.V. Fluid transfer - Product Code LHI
  • Reason
    Baxter healthcare corporation is voluntarily recalling one lot of baxa vial adapters, 14mm - luer lock, due to incorrect expiry date.
  • Action
    An Urgent Product Recall notification was mailed to one customer via USPS First Class mail on 8/22/13. The one customer affected by this action was instructed to locate and remove the affected product from inventory and to return to Baxter for credit and/or replacement. Any customer returns received will be discarded per the Corporate Hold.

Device

Device Recall Baxa Vial Adapter, 14mm Luer Lock
  • Model / Serial
    Lot or Serial No. 785518
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to One Customer in NC.
  • Product Description
    Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. || Used as a needleless access device for reconstitution and drug transfer.
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • Manufacturer Address
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Source
    USFDA