Sorin Group Smart Perfusion Pack E-Pack — Class III medical device recall Z-0664-2018
Terminated recall by LivaNova USA, reported 2018-02-28. The product is labeled with the incorrect expiration date.
| Recall number | Z-0664-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA, Arvada, CO, United States |
| Recall initiated | 2017-12-19 |
| Classified | 2018-02-21 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-08-11 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00803622108075 |
| Lot numbers | 1717800062, 1720800071 |
| Model numbers | 088511400 |
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.
Reason for recall
The product is labeled with the incorrect expiration date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0664-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.