Class II — Terumo Cardiovascular Systems Corporation
| Recalling firm | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
|---|---|
| Registered facility | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Presence of natural rubber latex is not declared in the label |
| Product | Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 |
| Quantity | 12 packs |
| Distribution | TX |
| Initiated | 2018-12-20 |
| Classified | 2019-02-27 |
| Terminated | 2019-08-20 |
| Recall number | Z-0966-2019 |
| 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 Corporation (Z-0966-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82019/
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