Events

Recall of Device Recall HEP LOCK

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
    46912
  • Event Risk Class
    Class 2
  • Event Number
    Z-1387-2008
  • Event Initiated Date
    2008-02-28
  • Event Date Posted
    2008-04-04
  • 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=68468
  • 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
    Heparin Lock Flush Solution, USP - Product Code NZW
  • Reason
    Due to an increase of adverse events in baxter single and multi-dose heparin for injection products, which used the same active pharmaceutical ingredient (api) source as the hep lock products.
  • Action
    A Press Release was issued on February 28, 2008. Recall notification letters , Urgent Product Recall, were sent on February 29, 2008, by overnight mail to customers/wholesalers/ distributors and dialysis center/renal home patients. Recall letters were also sent on March 7, 2008, to health care professionals

Device

Device Recall HEP LOCK
  • Model / Serial
    All Lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --Worldwide: USA including Puerto Rico, and countries of Germany, Guam, America Samoa, Marshal Islands, Northern Mariana Island/Virgin Islands, and Qatar . Accounts included wholesalers, pharmacies, hospitals, and clinic/renal home patients
  • Product Description
    Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, || 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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