FDA Device recall Z-3281-2018
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…
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of 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… by Stryker Neurovascular, citing the AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3281-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-02 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Neurovascular |
| Distribution | CO, NJ, NY, OH, PA, WV |
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, One Long Dilator.
Reason
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Identifiers
| code_info | Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3281-2018%22
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