Drug recall
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The…
FDA recall event 85198 · Class II · Alcon Research LLC
Key facts
| Event ID | 85198 |
|---|---|
| Recall numbers | Z-1794-2020 |
| Recalling firm | Alcon Research LLC |
| Product type | Devices |
| Products | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula. |
| Initiation date | Jul 25, 2018 |
| Report date | Apr 29, 2020 |
| Termination date | Apr 24, 2020 |
| 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: