Device recall
Z-2098-2019: A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped…
FDA device recall · Class II · Alto Development Corp
Key facts
| Recall number (Z-number) | Z-2098-2019 |
|---|---|
| Recall event | 83285 |
| Product | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a… |
| Product code | LDF |
| Recalling firm | Alto Development Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2020 |
| 510(k) numbers | K803086 |
| FEI number | 2242056 |
At a glance
- 1–9 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