Drug recall
Alcon Custom Pak Surgical Procedure Pack
FDA recall event 91105 · Class II · Alcon Research, LLC
Key facts
| Event ID | 91105 |
|---|---|
| Recall numbers | Z-0354-2023 |
| Recalling firm | Alcon Research, LLC |
| Product type | Devices |
| Products | Alcon Custom Pak Surgical Procedure Pack |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an… |
| Initiation date | Oct 31, 2022 |
| Report date | Dec 7, 2022 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 1000117501 |
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: