Device recall
Z-1708-2019: Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO…
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-1708-2019 |
|---|---|
| Recall event | 82755 |
| Product | Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the… |
| Product code | DQY |
| Recalling firm | Stryker Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 510(k) numbers | K172468 |
| 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