Drug recall
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03…
FDA recall event 90437 · Class II · Alcon Research, LLC
Key facts
| Event ID | 90437 |
|---|---|
| Recall numbers | Z-1373-2022 |
| Recalling firm | Alcon Research, LLC |
| Product type | Devices |
| Products | Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. |
| Initiation date | Jun 9, 2022 |
| Report date | Jul 20, 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: