Device recall
Z-1618-2021: Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging…
FDA device recall · Class II · Medtronic Inc.
Key facts
| Recall number (Z-number) | Z-1618-2021 |
|---|---|
| Recall event | 87476 |
| Product | Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not… |
| Product code | MDS |
| Recalling firm | Medtronic Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3003166194 |
At a glance
- None Linked 510(k)s
- 10–99 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