Recall Z-2856-2011 ยท LGB Gonococcal Antibody Tests
Pall Corporation
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 leu
| Date | Jul 21, 2011 (initiated May 26, 2011) |
| Status | Terminated |
| Reason | Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure. |
| 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 | 232 units |
| Distribution | Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE Pall Biomedical Products Co., Oct 16, 1990 |