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 | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators |
| Product | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass… |
| Quantity | 15 kits |
| Distribution | Nationwide Distribution including CA, CT , FL , WI. |
| Initiated | 2015-08-24 |
| Classified | 2015-09-18 |
| Terminated | 2016-02-05 |
| Recall number | Z-2790-2015 |
| 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-2790-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72010/
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