Events

Recall of Device Recall Sterile EXACTAMED Oral Liquid Dispenser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare 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
    79090
  • Event Risk Class
    Class 2
  • Event Number
    Z-0806-2018
  • Event Initiated Date
    2018-02-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161319
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • Reason
    Affected lot of 5 ml oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (h93876101) and volume (1ml).
  • Action
    Customers were notified via letter on about 02/06/2018. Instructions include to locate and remove affected product in inventory, confirm mislabeled 5 mL oral dispensers (Lot number 1203395) in the individual pouch are not mixed together with 1 mL oral dispensers (Product code H93876101) or other stored product, contact Baxter Healthcare Center to arrange return of affected product, and complete and return the customer reply form if purchased directly from Baxter. Also, customer are instructed to notify customers and conduct a consumer-level recall if the affected product was further distributed. Questions and concerns can be directed to the Public Contact, Center for One Baxter with phone number (Toll Free) 800-422-9837 and 847-948-4770, Monday through Friday 8:00 AM to 5:00 PM CST.

Device

Device Recall Sterile EXACTAMED Oral Liquid Dispenser
  • Model / Serial
    Lot No. 1203395, Expiration Date 11/30/2019
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
  • Product Description
    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

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