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.
Reported: October 10, 2018 Initiated: May 2, 2018 #Z-3281-2018
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.
Details
- Recalling Firm
- Stryker Neurovascular
- Units Affected
- 15 units
- Distribution
- Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Neurovascular. Units affected: 15 units.
Why was this product recalled? ▼
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-3281-2018.
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