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Terminated

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

FDA Recall Z-1229-2020 · Posted None

Recalling FirmTaewoong Medical Co., Ltd.
Recall StatusTerminated
Product CodeESW
Date Initiated2019-10-18
Date Terminated2021-10-15
Product Quantity178

Reason for Recall

Misprinted IFUs shipped with esophageal stents

Firm Action

On 10/18/19, an Esophageal Stent Device Return notices were emailed to the U.S. distributor who was asked to stop releasing products. The distributor was further asked to do the following for products already distributed: please send customers a notification to stop using the product immediately and to return affected product. Then the distributor was asked to return all affected products in their possession including returned products to the manufacturer. e-mail contact: [email protected]

Root Cause

Error in labeling

Distribution Pattern

U.S.: IN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123205ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd. · 2013-10-09K113551ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd. · 2012-02-14K080782NITI-S ESOPHAGEAL STENTTaewoong Medical Co., Ltd. · 2009-01-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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