Device recall
Z-0658-06: Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro…
FDA device recall · Class II · Smiths Medical MD, Inc.
Key facts
| Recall number (Z-number) | Z-0658-06 |
|---|---|
| Recall event | 34691 |
| Product | Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20… |
| Product code | FPA |
| Recalling firm | Smiths Medical MD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2007 |
| 510(k) numbers | K811933, K823406 |
| FEI number | 2183502 |
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