Device recall
Z-0464-05: 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-0464-05 |
|---|---|
| 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 8C390 (Reorder No. 21-0325-01) 121 inch length/307 cm, 28ml priming volume, 20 drops/ml, 0 injection sites. |
| 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