Drug recall
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721…
FDA recall event 73767 · Class II · Alcon Research, Ltd.
Key facts
| Event ID | 73767 |
|---|---|
| Recall numbers | Z-1597-2016 |
| Recalling firm | Alcon Research, Ltd. |
| Product type | Devices |
| Products | INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs. |
| Initiation date | Oct 6, 2014 |
| Report date | May 11, 2016 |
| Termination date | Mar 31, 2017 |
| City | Fort Worth |
| State | TX |
| Country | United States |
| FEI number | 1610287 |
At a glance
- 1–9 Products in this recall
- None 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: