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.
FDA Recall Z-2856-2011 · Posted 2011-07-21
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Recalling FirmPall Corporation
Recall StatusTerminated
Product CodeLGB
Date Initiated2011-05-26
Date Terminated2012-10-03
Product Quantity232 units
Reason for Recall
Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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