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Taewoong Medical Co., Ltd. recalls Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, E
Recalled February 19, 2020 · FDA recall Z-1229-2020 · Taewoong Medical
Hazard
Misprinted IFUs shipped with esophageal stents · FDA Class II
Units
178
Sold at
U.S.: IN
Description
Misprinted IFUs shipped with esophageal stents
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
Manufacturer(s)
Taewoong Medical Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →