Stryker Neurovascular recalls AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN

Recalled October 10, 2018 · FDA recall Z-3281-2018 · Stryker Neurovascular

Hazard

The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. · FDA Class II

Units

15 units

Sold at

Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.

Description

The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

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.

Manufacturer(s)

Stryker Neurovascular

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →