Device recall
Z-2221-2010: BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA…
FDA device recall · Class II · Insight Instruments, Inc.
Key facts
| Recall number (Z-number) | Z-2221-2010 |
|---|---|
| Recall event | 56246 |
| Product | BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411). Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. Item # 40201: Item Lot #… |
| Product code | KYG |
| Recalling firm | Insight Instruments, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2012 |
| FEI number | 1052234 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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