Device recall
Z-0229-2020: Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN…
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-0229-2020 |
|---|---|
| Recall event | 81108 |
| Product | Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures. |
| Product code | DQX |
| Recalling firm | Stryker Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K190843 |
| FEI number | 3008853977 |
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