Reported Feb 19, 2020 · Terminated

Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B,…

Taewoong Medical Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Taewoong Medical Co., Ltd. · 14 Gojeong-ro, Wolgot-Myeon, · Gyeonggi-Do · N/A

Lot codes and dates: 178 of 178 codes
Serial #: 16D5429C9IE565
16K4777C9IE566
16K4066C9IE567
17H3384C9IE568
16L1711C9IE589
18K4093C9IE590
19H4952C9IE515
19F2183C9IE516
19H4108C9IE517
19H2616C9IE518
19H3454C9IE519
19F2181C9IE520
18K1514C9IE521
19F2182C9IE522
19H4107C9IE523
19F0992C9IE524
18K4123C9IE525
19E5708C9IE526
19E5232C9IE527
19F4232C9IE528
19H2615C9IE529
19H3455C9IE530
19H4897C9IE531
19B4591C9IE532
19H3052C9IE533
19A5788C9IE534
19C7871C9IE535
19D7958C9IE536
19F5937C9IE537
19G0615C9IE538
19G1204C9IE539
19G2208C9IE540
19G3296C9IE541
19G3421C9IE542
19G3422C9IE543
19G4536C9IE544
19G4537C9IE545
19G4558C9IE546
19G4559C9IE547
19G4952C9IE548
19G5440C9IE549
19G6408C9IE550
19G7534C9IE551
19G7535C9IE552
19H3453C9IE553
19H4278C9IE554
19H4279C9IE555
19H4576C9IE556
19H4852C9IE557
19H4979C9IE558
19H4980C9IE559
19H1215C9IE560
19H4088C9IE561
19H4577C9IE562
19H4629C9IE563
19H4851C9IE564
19D7674C9IE569
19E0233C9IE570
19E2071C9IE571
19E3052C9IE572
Amount recalled: 178

Misprinted IFUs shipped with esophageal stents

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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