Device recall
Z-2179-2014: Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage…
FDA device recall · Class II · Medtronic MiniMed Inc.
Key facts
| Recall number (Z-number) | Z-2179-2014 |
|---|---|
| Recall event | 68888 |
| Product | Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose… |
| Product code | MDS |
| Recalling firm | Medtronic MiniMed Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2014 |
| 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