FDA recall Z-0277-2018

Product

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

Reason for recall

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.

Distribution

International Distribution to: Germany, Slovakia and Israel.

Key facts

Status

Terminated

Initiation date

2017-11-03

Report date

2017-12-27

Termination date

2019-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2018