Class II — Terumo Cardiovascular Systems Corp
| Recalling firm | Terumo Cardiovascular Systems Corp. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. |
| 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 Exhacorporeal Service is indicated for use only in the exhacorporeal 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 Le… |
| Quantity | 2677 |
| Distribution | US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL |
| Initiated | 2017-12-18 |
| Classified | 2018-04-06 |
| Terminated | 2019-04-09 |
| Recall number | Z-1314-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo Cardiovascular Systems Corp (Z-1314-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79524/
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