FDA recall Z-2799-2017

Product

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001

Reason for recall

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.

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2017-06-26

Report date

2017-08-09

Termination date

2021-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2799-2017