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.
Potential for the housing of the arterial line leukocyte reduction filter to separate before or during the priming procedure.
조치
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.
Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
제품 설명
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.