FDA recall Z-1229-2020

Product

Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F

Reason for recall

Misprinted IFUs shipped with esophageal stents

Distribution

U.S.: IN

Key facts

Status

Terminated

Initiation date

2019-10-18

Report date

2020-02-19

Termination date

2021-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gyeonggi-Do, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1229-2020