Drug recall
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
FDA recall event 85858 · Class III · LivaNova USA Inc.
Key facts
| Event ID | 85858 |
|---|---|
| Recall numbers | Z-2642-2020 |
| Recalling firm | LivaNova USA Inc. |
| Product type | Devices |
| Products | LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and… |
| Initiation date | Nov 18, 2019 |
| Report date | Jul 29, 2020 |
| Termination date | Aug 19, 2021 |
| 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: