Drug recall
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use…
FDA recall event 69743 · Class II · Alcon Research, Ltd.
Key facts
| Event ID | 69743 |
|---|---|
| Recall numbers | Z-0527-2015 |
| Recalling firm | Alcon Research, Ltd. |
| Product type | Devices |
| Products | Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers. |
| Initiation date | Nov 11, 2014 |
| Report date | Dec 17, 2014 |
| Termination date | Feb 4, 2016 |
| 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: