PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Nu
FDA device recall Z-2856-2011 · posted 2011-07-21 · Terminated
Recall details
- Recalling firm
- Pall Corporation
- Reason for recall
- Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.
- Action taken
- 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
- Status
- Terminated
- Product code
- LGB
- Quantity affected
- 232 units
- Distribution
- Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
- Date initiated
- 2011-05-26
- Date posted
- 2011-07-21
- Date terminated
- 2012-10-03
- Location
- Port Washington, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE (K902518) | Pall Biomedical Products Co. | 1990-10-16 |