Device recall
Z-1020-2007: All IV Administration Infusion Sets intended for use with the Gemini Infusion…
FDA device recall · Class II · Cardinal Health 303 Inc DBA Alaris Products
Key facts
| Recall number (Z-number) | Z-1020-2007 |
|---|---|
| Recall event | 38225 |
| Product | All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris Burette Set, Cardinal Health SmartSite Infusion Set, Alaris Infusion Set… |
| Product code | FRN |
| Recalling firm | Cardinal Health 303 Inc DBA Alaris Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2012 |
| 510(k) numbers | K862295 |
| FEI number | 3003879246 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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