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.
FDA Recall Z-3281-2018 · Posted None
Recalling FirmStryker Neurovascular
Recall StatusTerminated
Product CodeDQY
Date Initiated2018-05-02
Product Quantity15 units
Reason for Recall
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Firm Action
On 5/2/2018, "Urgent Medical Device Customer Communication" notifications were mailed via courier. Customers were informed to complete and return a Customer Acknowledgement Form. Customers with questions are encouraged to call (510) 413-2100.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.