FDA-Device2017-08-09Class II

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150

Stryker Neurovascular
Hazard

Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.

Sold states
nationwide
Affected count
48 units
Manufactured in
47900 Bayside Pkwy, N/A, Fremont, CA, United States
Products
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2802-2017

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