FDA recall Z-3281-2018

Stryker Neurovascular · Class II · 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.

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2018-05-02
Report date: 2018-10-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3281-2018