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 | Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. |
| Product | Cardiovascular Procedure Kit catalog # 76645 & 73806 |
| Quantity | 64 |
| Distribution | US Nationwide distribution in the states of CA and IN. |
| Initiated | 2022-02-03 |
| Classified | 2022-04-18 |
| Terminated | 2024-02-20 |
| Recall number | Z-0949-2022 |
| 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-0949-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89792/
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