Z-2856-2011

PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE...

Name: Z-2856-2011 PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE...
Creator: Pall Corporation
Published: 2011-05-26
License: https://open.fda.gov/license/

Pall Corporation / initiated 2011-05-26 / Terminated / root cause: manufacturing process

FDA source

Pall Corporation began a recall of PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter... on 2011-05-26. The reason FDA records is "Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2856-2011
Status: Terminated
Initiated: 2011-05-26
Posted: 2011-07-21
Terminated: 2012-10-03
Recalling firm: Pall Corporation
Product: 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.
Product code: LGB Gonococcal Antibody Tests
Reason for recall: Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 232 units
Distribution: Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
Product codes and lots: Catalog/Model/Reorder Number: LGB Lot # 10-405

Product code LGB

K902518Class IILd-Six Arterial Blood Filter for Extra. ServicePall Biomedical Products Co. / cleared 1990-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)