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.
This recall has been terminated (originally issued May 2, 2018).
- Company
- Stryker Neurovascular
- Recall Initiated
- May 2, 2018
- Recall Number
- Z-3281-2018
- Quantity
- 15 units
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Distribution
Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Lot / Code Info
Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
Root Cause
Nonconforming Material/Component
Action Taken
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.
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