Drug recall
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the…
FDA recall event 79000 · Class III · LivaNova USA
Key facts
| Event ID | 79000 |
|---|---|
| Recall numbers | Z-0664-2018 |
| Recalling firm | LivaNova USA |
| Product type | Devices |
| Products | 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. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product is labeled with the incorrect expiration date. |
| Initiation date | Dec 19, 2017 |
| Report date | Feb 28, 2018 |
| Termination date | Aug 11, 2020 |
| City | Arvada |
| State | CO |
| Country | United States |
| FEI number | 1718850 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: