Device recall
Z-0443-2013: Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All…
FDA device recall · Class II · Parks Medical Electronics, Inc
Key facts
| Recall number (Z-number) | Z-0443-2013 |
|---|---|
| Recall event | 63235 |
| Product | Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C… |
| Product code | DPW |
| Recalling firm | Parks Medical Electronics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2016 |
| 510(k) numbers | K944495 |
| FEI number | 3020115 |
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