Device recall
Z-0524-2015: Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm…
FDA device recall · Class II · Medtronic MiniMed Inc.
Key facts
| Recall number (Z-number) | Z-0524-2015 |
|---|---|
| Recall event | 69720 |
| Product | Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862… |
| Product code | FPA |
| Recalling firm | Medtronic MiniMed Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2015 |
| 510(k) numbers | K002138 |
| FEI number | 3003166194 |
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