Gyeonggi-Do, Korea (the Republic of)
Taewoong Medical Co., Ltd. recalls
1 recall recorded since 2018, most recently on 18 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 October 2019
- Terminated
- 15 October 2021
- Reason
- Misprinted IFUs shipped with esophageal stents
- Distribution
- U.S.: IN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1229-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.