Device recall
Z-2442-2015: Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or…
FDA device recall · Class II · Medtronic MiniMed Inc.
Key facts
| Recall number (Z-number) | Z-2442-2015 |
|---|---|
| Recall event | 71816 |
| Product | Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. |
| Product code | MDS |
| Recalling firm | Medtronic MiniMed Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2015 |
| PMA numbers | P980022 |
| FEI number | 3003166194 |
At a glance
- None 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