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 | Kit was labeled with the incorrect Expiration Date of April 30, 2019. |
| Product | Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it. |
| Quantity | 30 cases/2 units (Total 60 units) |
| Distribution | US state of FL |
| Initiated | 2017-05-12 |
| Classified | 2018-07-26 |
| Terminated | 2018-10-26 |
| Recall number | Z-2550-2018 |
| 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-2550-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80283/
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