Device 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.
Z-3281-2018
Product summary
- Event
- Event 80652
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-3281-2018
Official wording
Reason: The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Code information: Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
Distribution pattern: Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Derived failure modes
-
Unknown
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.