Recall Z-1229-2020 ยท ESW Prosthesis, Esophageal
Taewoong Medical Co., Ltd.
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
| Date | Oct 18, 2019 |
| Status | Terminated |
| Reason | Misprinted IFUs shipped with esophageal stents |
| Root cause | Error in labeling |
| 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: bclee@stent.net |
| Quantity | 178 |
| Distribution | U.S.: IN |
| FDA record | Open on fda.gov |