Taewoong Medical Co., Ltd. recalls Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B,…

Recall date

October 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1229-2020

FDA classification

Class II

Brand / firm

Taewoong Medical Co., Ltd.

Sold / distributed

U.S.: IN

Why it was recalled

Misprinted IFUs shipped with esophageal stents

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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