Device recall
Z-3281-2018: AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x…
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-3281-2018 |
|---|---|
| Recall event | 80652 |
| Product | AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing… |
| Product code | DQY |
| Recalling firm | Stryker Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| 510(k) numbers | K152876 |
| 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