FDA recall Z-0221-2022

Product

SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Reason for recall

There is a potential for distal tip dislodgement or separation.

Distribution

US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.

Key facts

Status

Ongoing

Initiation date

2021-10-01

Report date

2021-11-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0221-2022