FDA-Device2018-10-10Class II
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.
Stryker Neurovascular
Hazard
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Sold states
Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Affected count
15 units
Manufactured in
47900 Bayside Pkwy, Fremont, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3281-2018Don't want to check this manually?
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