Events

Recall of Device Recall Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pall 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
    59259
  • Event Risk Class
    Class 2
  • Event Number
    Z-2856-2011
  • Event Initiated Date
    2011-05-26
  • Event Date Posted
    2011-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102068
  • 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
    Arterial Line, Cardiopulmonary Bypass, Blood Filter System - Product Code LGB
  • Reason
    Potential for the housing of the arterial line leukocyte reduction filter to separate before or during the priming procedure.
  • Action
    Pall Medical sent an "Important Customer Notification" letter dated May 26, 2011 to all affected customers. The letter included a description of the problem, affected lots and provided recommendations including the return of the product. For additional information, please contact the firm at (516) 484-0263.

Device

Device Recall Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop
  • Model / Serial
    Catalog/Model/Reorder Number: LGB Lot # 10-405
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
  • Product Description
    PALL Medical LeukoGuard¿ LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial Line. COMMON/USUAL NAME: Arterial Line Filter with Bypass Loop. -- Manufactured by: PALL NEWQUAY, CORNWALL, TR9 6TT, UK -- Device Listing # D000745. --- Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris.
  • Manufacturer
    Pall Corporation

Manufacturer

Pall Corporation
  • Manufacturer Address
    Pall Corporation, 25 Harbor Park Drive, Port Washington NY 11050-4605
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA