Device recall
Z-0138-04: IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package…
FDA device recall · Class II · Merit Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-0138-04 |
|---|---|
| Recall event | 27525 |
| Product | IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE WIRE INSERTION TOOL...MERIT MEDICAL'', Latex free. Sterile if package is… |
| Product code | DXT |
| Recalling firm | Merit Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2004 |
| 510(k) numbers | K884913 |
| FEI number | 1721504 |
At a glance
- 1–9 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