Class III — LivaNova USA
| Recalling firm | LivaNova USA, Inc. |
|---|---|
| Registered facility | LivaNova USA, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The product is labeled with the incorrect expiration date. |
| Product | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. |
| Quantity | 16 units (6 from lot 1717800062 and 10 units from lot 1720800071 |
| Distribution | Distribution was made to one consignee in LA. |
| Initiated | 2017-12-19 |
| Classified | 2018-02-21 |
| Terminated | 2020-08-11 |
| Recall number | Z-0664-2018 |
| 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 III recall — LivaNova USA (Z-0664-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79000/
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