Events

Recall of Baxter Duploject Easy Prep

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

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
    45489
  • Event Risk Class
    Class 2
  • Event Number
    Z-0263-2008
  • Event Initiated Date
    2007-10-25
  • Event Date Posted
    2007-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65608
  • 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
    Fibrin Sealant Preparation - Product Code FMF
  • Reason
    Sterility (package integrity) compromised: this recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.
  • Action
    An Urgent Product Recall Letter dated October 24, 2007, was issued with attached Product Recall Instructions and Customer Response forms to all consignees (Director of Materials Management, and Director of Risk Management). The recall letter requests sub recalls to the retail level and product quarantine and return. The recall notification letters were sent via commercial carrier (UPS Next Day Service).

Device

Baxter Duploject Easy Prep
  • Model / Serial
    Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252; Lot Numbers: 07B069, 07B070, 07B071, 07G025 & 07E026
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, Canada and European Union (France and UK)
  • Product Description
    Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Bioscience

Manufacturer

Baxter Bioscience
  • Manufacturer Address
    Baxter Bioscience, 1 Baxter Way, Westlake Village CA 91362-3811
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA