Device recall
Z-1984-2019: Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various…
FDA device recall · Class II · Medline Industries, Inc.
Key facts
| Recall number (Z-number) | Z-1984-2019 |
|---|---|
| Recall event | 83000 |
| Product | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF… |
| Product code | OCT |
| Recalling firm | Medline Industries, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K982465 |
| FEI number | 3000717925 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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