FDA-Device2017-12-27Class II
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
Stryker Neurovascular
Hazard
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Sold states
International Distribution to: Germany, Slovakia and Israel.
Affected count
1 unit
Manufactured in
47900 Bayside Pkwy, Fremont, CA, United States
Products
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2018Don't want to check this manually?
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