Devices

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

Manufacturer

Pall Corporation

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

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