Device recall
Z-0428-2012: Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0428-2012 |
|---|---|
| Recall event | 60516 |
| Product | Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and… |
| Product code | LGZ |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2014 |
| 510(k) numbers | K911383 |
| FEI number | 1221261 |
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