FDA Device recall Z-1314-2018
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters by Terumo Cardiovascular Systems, citing possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1314-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-18 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | AL, FL, GA, NC, NY, OH, VA |
Product
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ Leukocy1e Reduction Arterial Blood Filter for Exh¿acorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 ¿m in size from the perfu sate during exh¿acorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard ¿ Leukocyte Reduction Arterial Blood Filter can be included in Cardiovascular Procedure Kits (Convenience Kits). When the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters is included in the Kits, the intended use of the filter remains unaffected.
Reason
Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
Identifiers
| code_info | 662143 735568 752561 767041 774364 775404 778816 783025 785629 794402 794411 735568 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.