—#166111

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K152876
Affected lot / code info: Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

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

Timeline

Recall initiated: 2018-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.