Device recall
Z-0095-2021: Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS"…
FDA device recall · Class II · Alcon Research, LLC
Key facts
| Recall number (Z-number) | Z-0095-2021 |
|---|---|
| Recall event | 86315 |
| Product | Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries. |
| Product code | LRO |
| Recalling firm | Alcon Research, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2021 |
| 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