Reported Oct 10, 2018 · Terminated
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm…
Stryker Neurovascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
- 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 areOne (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator
- Lot codes and dates
- Lot No. 20156091
- UPNGEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
This product could cause temporary or reversible health problems — stop using it.
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