Device recall
Z-2995-2026: Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit…
FDA device recall · Class II · Medline Industries, LP
Key facts
| Recall number (Z-number) | Z-2995-2026 |
|---|---|
| Recall event | 99489 |
| Product | Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641. |
| Product code | LRO |
| Recalling firm | Medline Industries, LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213481 |
| FEI number | 1417592 |
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