Device recall
Z-1373-2022: Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK…
FDA device recall · Class II · Alcon Research, LLC
Key facts
| Recall number (Z-number) | Z-1373-2022 |
|---|---|
| Recall event | 90437 |
| Product | 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 SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK… |
| Product code | LRO |
| Recalling firm | Alcon Research, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K880961 |
| FEI number | 1000117501 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database