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U.S. Department of Health and Human Services

Class 2 Device Recall AXS Infinity LS Long Sheath

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  Class 2 Device Recall AXS Infinity LS Long Sheath see related information
Date Initiated by Firm May 02, 2018
Create Date September 28, 2018
Recall Status1 Terminated 3
Recall Number Z-3281-2018
Recall Event ID 80652
510(K)Number K152876  
Product Classification Catheter, percutaneous - Product Code DQY
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.
Code Information Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
Manufacturer Reason
for Recall		 The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
FDA Determined
Cause 2		 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 in Commerce 15 units
Distribution Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = TNI Manufacturing, Inc.
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