Device recall
Z-0469-05: Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby…
FDA device recall · Class II · Smiths Medical MD, Inc.
Key facts
| Recall number (Z-number) | Z-0469-05 |
|---|---|
| Recall event | 30603 |
| Product | Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter. |
| Product code | FPA |
| Recalling firm | Smiths Medical MD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2006 |
| 510(k) numbers | K811933, K823406 |
| FEI number | 2183502 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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