Z-3281-2018 Class II Terminated
FDA device recall Z-3281-2018 was initiated by Stryker Neurovascular on May 2, 2018 and is designated Class II. Reason for recall: The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. The recall status is terminated. Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- May 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
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 Pattern
Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Code Information
Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3281-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026