Device recall
Z-1143-2015: Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product…
FDA device recall · Class II · Angiodynamics
Key facts
| Recall number (Z-number) | Z-1143-2015 |
|---|---|
| Recall event | 70388 |
| Product | Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615 |
| Product code | GEI |
| Recalling firm | Angiodynamics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2015 |
| 510(k) numbers | K992693 |
| FEI number | 3017892510 |
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