Recall Z-3281-2018 ยท DQY Catheter, Percutaneous
Stryker Neurovascular
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.
| Date | May 2, 2018 |
| Status | Terminated |
| Reason | The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 15 units |
| Distribution | Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152876 | LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM Tni Manufacturing, Inc., Jan 8, 2016 |