Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loopsee related information
Date Initiated by FirmMay 26, 2011
Date PostedJuly 21, 2011
Recall Status1 Terminated 3 on October 03, 2012
Recall NumberZ-2856-2011
Recall Event ID 59259
510(K)NumberK902518 
Product Classification Arterial Line, Cardiopulmonary Bypass, Blood Filter System - Product Code LGB
ProductPALL 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.
Code Information Catalog/Model/Reorder Number: LGB Lot # 10-405
FEI Number 2432733
Recalling Firm/
Manufacturer		 Pall Corporation
25 Harbor Park Drive
Port Washington NY 11050-4605
For Additional Information ContactKaren Peterson-Doyle
516-801-9267
Manufacturer Reason
for Recall		Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.
FDA Determined
Cause 2		Process control
ActionPall 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.
Quantity in Commerce232 units
DistributionNationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LGB
-
-