Events

Recall of Device Recall Millipore

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Millipore 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
    28223
  • Event Risk Class
    Class 2
  • Event Number
    Z-0576-04
  • Event Initiated Date
    2004-01-26
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31481
  • 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
    Filter, Infusion Line - Product Code FPB
  • Reason
    Lack of assurance of sterility.
  • Action
    Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts.

Device

Device Recall Millipore
  • Model / Serial
    Lot Numbers: F2JN63560 F2KN78263 F2MN78127 F2NN78129 F2NN86699 F2PN69885 R3AN96873 R3AN96873Q R3AN97497 R3AN97497Q R3DN04753 R3DN04754 R3HN06269 R3HN06271 R3HN06272 R3HN89115 R3HN89117 R3JN94935 R3JN94936 R3JN94938 R3JN94940
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
  • Product Description
    Millex GS- Syringe Filter 0.22um, Sterile || Catalog Number: SLGS033SS
  • Manufacturer
    Millipore Corp.

Manufacturer

Millipore Corp.
  • Manufacturer Address
    Millipore Corp., 80 Ashby Rd, Bedford MA 01730-2237
  • Source
    USFDA