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텔레플렉스

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의료기술 혁신, 텔레플렉스

의료기기 회수에 관한 공표 (EIF-000537)

작성자 : 관리자 2023.07.20

<의료기기 회수에 관한 공표>

 

의료기기법 제 31조 및 제 34조 규정에 따라 아래의 의료기기에 대하여 회수함을 공표합니다.

. 회수의무자: 텔레플렉스코리아() (전화: 02-536-7550)

. 회수대상의료기기 

 

 

조치방법

Recall

Teleflex Reference

EIF-000537

제품명

SAFETY CLEAR TRACHEAL TUBE UNCUFF

TRACHEAL TUBE, CUFFED, NASAL PREFORMED

TRACHEAL TUBE, CUFFED

품목명

단기사용기관·기관지용튜브·카테터

허가번호

수인09-175

제품코드

아래 표 참조

제조번호

아래 표 참조

 

. 위해성 정도: 위해성 정도 2

. 회수사유: 해외제조원의 자발적 회수 - 기관내관(Endotracheal tube, ET tube)에서 15mm 커넥터(connector)가 분리

. 회수방법: 안내문 전달과 함께 병원 및 대리점 재고 회수 진행

. 회수기간: 2023-05-30 ~

. 공표자료 작성연월일: 2023-06-01 

 

* 해당 회수대상 의료기기를 보관하고 있는 판매업체 및 의료기관 등에서는 즉시 판매, 사용을 중지하고 회수를 위하여 연락주시기 바랍니다.

 

회수대상 의료기기

품번

LOT No.

품번

LOT No.

품번

LOT No.

100382-2.0

19HT36

112482-3.5

KME22D1015

112482-6.5

18KT27

100382-2.0

19HT80

112482-3.5

KME22E0559

112482-6.5

18LG33

100382-2.0

19KT38

112482-3.5

KME22F3266

112482-6.5

18LT16

100382-2.5

18JG14

112482-3.5

KME22F3300

112482-6.5

19AT20

100382-2.5

19HT79

112482-3.5

KME22G0357

112482-6.5

19DT46

100382-2.5

19IT58

112482-3.5

KME22J1776

112482-6.5

19ET57

100382-2.5

19KT08

112482-4.0

18FG14

112482-6.5

19ET83

100382-2.5

KME21K1729

112482-4.0

18FT13

112482-6.5

19GT14

100382-3.0

19ET31

112482-4.0

18KG09

112482-6.5

19GT55

100382-3.0

19ET51

112482-4.0

18KG25

112482-6.5

19HT59

100382-3.0

19FT08

112482-4.0

18LG05

112482-6.5

19HT73

100382-3.0

19JT21

112482-4.0

18LG30

112482-6.5

19IT42

100382-3.0

20DT02

112482-4.0

19FT12

112482-6.5

19IT57

100382-3.0

KME21A2356

112482-4.0

19HT26

112482-6.5

19JT05

100382-3.0

KME21B0570

112482-4.0

19IT56

112482-6.5

20BG18

100382-3.5

18KG24

112482-4.0

20ET03

112482-6.5

20BT22

100382-3.5

19AG21

112482-4.0

20FT21

112482-6.5

KME20H1194

100382-3.5

19JT51

112482-4.0

20GT18

112482-6.5

KME20H2994

100382-3.5

20DT02

112482-4.0

KME20H1630

112482-6.5

KME20J0259

100382-3.5

20FT55

112482-4.0

KME20J0755

112482-6.5

KME20J0543

100382-3.5

KME21J0627

112482-4.0

KME20J0758

112482-6.5

KME20J0868

100382-4.0

19ET09

112482-4.0

KME20J0926

112482-6.5

KME20J1373

100382-4.0

19FT12

112482-4.0

KME20J1921

112482-6.5

KME21A0919

111781-3.5

18GT32

112482-4.0

KME20J2656

112482-6.5

KME21A1023

111781-4.0

20AT53

112482-4.0

KME20K0272

112482-6.5

KME21A1107

111781-4.0

20DT35

112482-4.0

KME20K0851

112482-6.5

KME21A1814

111781-4.0

20FT60

112482-4.0

KME21A0958

112482-6.5

KME21J0386

111781-4.0

KME20H3000

112482-4.0

KME21A3145

112482-6.5

KME21J0466

111781-4.0

KME20J2135

112482-4.0

KME21B0536

112482-6.5

KME21J1167

111781-4.0

KME20K1125

112482-4.0

KME21C0773

112482-6.5

KME21J1210

111781-4.0

KME20K3666

112482-4.0

KME21C1406

112482-6.5

KME21K1086

111781-4.0

KME20L2240

112482-4.0

KME21K1981

112482-6.5

KME21K1087

111781-4.0

KME20M2795

112482-4.0

KME21K1982

112482-6.5

KME21L0139

111781-4.0

KME21A1003

112482-4.0

KME21K2816

112482-6.5

KME21L0140

111781-4.0

KME21A1004

112482-4.0

KME22B0162

112482-6.5

KME21L0142

111781-4.0

KME21B1287

112482-4.0

KME22B1759

112482-6.5

KME21L1815

111781-4.5

19GT16

112482-4.0

KME22C0807

112482-6.5

KME21L1979

111781-4.5

19HT55

112482-4.0

KME22D1016

112482-6.5

KME21L1981

111781-4.5

19KT14

112482-4.0

KME22D2649

112482-6.5

KME21L1982

111781-4.5

19KT46

112482-4.0

KME22F1439

112482-6.5

KME21L1983

111781-4.5

20AT22

112482-4.0

KME22G2947

112482-6.5

KME21L1984

111781-4.5

KME20J2134

112482-4.5

18FG14

112482-6.5

KME21L1988

111781-4.5

KME20L2665

112482-4.5

18FT13

112482-6.5

KME21L1990

111781-4.5

KME20M0333

112482-4.5

18JG09

112482-7.0

18HG04

111781-4.5

KME20M0593

112482-4.5

18LG30

112482-7.0

18HT05

111781-4.5

KME20M2794

112482-4.5

19AG07

112482-7.0

18KG09

111781-4.5

KME21A1181

112482-4.5

19AG38

112482-7.0

18KG11

111781-4.5

KME21A2027

112482-4.5

19ET09

112482-7.0

18KG14

111781-5.0

18FG20

112482-4.5

19FT08

112482-7.0

19AT19

111781-5.0

18GG23

112482-4.5

19GT46

112482-7.0

19AT20

111781-5.0

18HG19

112482-4.5

19HT26

112482-7.0

19BG35

111781-5.0

18IG15

112482-4.5

19HT60

112482-7.0

19CG05

111781-5.0

18IG17

112482-4.5

19JT50

112482-7.0

19CG07

111781-5.0

18LG30

112482-4.5

20AT39

112482-7.0

19CT03

111781-5.0

18LG39

112482-4.5

20FT21

112482-7.0

19CT34

111781-5.0

19DT05

112482-4.5

KME20H1631

112482-7.0

19CT82

111781-5.0

19ET61

112482-4.5

KME20H2415

112482-7.0

19DT05

111781-5.0

19HT24

112482-4.5

KME20J0787

112482-7.0

19DT46

111781-5.0

19LT17

112482-4.5

KME20K2019

112482-7.0

19ET74

111781-5.0

20BT53

112482-4.5

KME20K3356

112482-7.0

19FT21

111781-5.0

20ET34

112482-4.5

KME20L2037

112482-7.0

19GT25

111781-5.0

KME20J1855

112482-4.5

KME20L2343

112482-7.0

20AT01

111781-5.0

KME20L2241

112482-4.5

KME20M0787

112482-7.0

20FT45

111781-5.0

KME20M2644

112482-4.5

KME20M2496

112482-7.0

20GT09

111781-5.0

KME21A1025

112482-4.5

KME21A0771

112482-7.0

20GT32

111781-5.0

KME21A1026

112482-4.5

KME21B1093

112482-7.0

KME20H2462

111781-5.0

KME21A1061

112482-4.5

KME21B1098

112482-7.0

KME20J0358

111781-5.0

KME21B0254

112482-4.5

KME21B1787

112482-7.0

KME20J0541

111781-5.0

KME21B2346

112482-4.5

KME21B2179

112482-7.0

KME20J0934

111781-5.0

KME21B2534

112482-4.5

KME22D1840

112482-7.0

KME20J1001

111781-5.5

20BT02

112482-4.5

KME22E0994

112482-7.0

KME20J1273

111781-5.5

KME20K1680

112482-4.5

KME22E1248

112482-7.0

KME20J3283

111781-5.5

KME20L2671

112482-4.5

KME22F1690

112482-7.0

KME21D2843

111781-5.5

KME21A1083

112482-4.5

KME22F1758

112482-7.0

KME21D2865

111781-5.5

KME21B1755

112482-5.0

18HG10

112482-7.0

KME21E0850

111781-5.5

KME21B1824

112482-5.0

18HG17

112482-7.0

KME21E1040

111781-6.0

KME20J0428

112482-5.0

18HG19

112482-7.0

KME21E1101

111781-6.5

19IT01

112482-5.0

18HT08

112482-7.0

KME21F0181

111781-6.5

20FT64

112482-5.0

18KG16

112482-7.0

KME21F0308

111781-6.5

KME20H0433

112482-5.0

18KG22

112482-7.0

KME21G1378

111781-6.5

KME20H0539

112482-5.0

19ET09

112482-7.0

KME21G1612

111781-6.5

KME20H2680

112482-5.0

19GT25

112482-7.0

KME21G1613

111781-6.5

KME20J1215

112482-5.0

19GT46

112482-7.0

KME21G1625

111781-6.5

KME20J2129

112482-5.0

19IT61

112482-7.0

KME21K0092

111781-6.5

KME20K1129

112482-5.0

19JT51

112482-7.0

KME21K0096

111781-6.5

KME20K1130

112482-5.0

19KT37

112482-7.0

KME21K0594

111781-6.5

KME21C1883

112482-5.0

20BG18

112482-7.0

KME21K0595

111781-7.0

KME20H2682

112482-5.0

20ET44

112482-7.0

KME21K0835

111781-7.0

KME20J0430

112482-5.0

KME20H1115

112482-7.0

KME21K1088

111781-7.0

KME20J3008

112482-5.0

KME20H3008

112482-7.0

KME21K2230

111781-7.0

KME20J3030

112482-5.0

KME20J1183

112482-7.0

KME22D2155

111781-7.0

KME20K1131

112482-5.0

KME20J2251

112482-7.5

18FG07

111781-7.0

KME20K1681

112482-5.0

KME20K2669

112482-7.5

18FG14

111781-7.0

KME20K3650

112482-5.0

KME21A1152

112482-7.5

18FT06

111781-7.0

KME21A2186

112482-5.0

KME21A1280

112482-7.5

18HG33

112482-2.5

19HT05

112482-5.0

KME21B2169

112482-7.5

18HG36

112482-2.5

19IT11

112482-5.0

KME21D1704

112482-7.5

18HT11

112482-2.5

20AT06

112482-5.0

KME21G0859

112482-7.5

18KG30

112482-2.5

20FT68

112482-5.0

KME21G2441

112482-7.5

18LG33

112482-2.5

20GT18

112482-5.0

KME21J1480

112482-7.5

19BG33

112482-2.5

KME20J0634

112482-5.0

KME21K0148

112482-7.5

19BT18

112482-2.5

KME20J0635

112482-5.0

KME21K1209

112482-7.5

19CT82

112482-2.5

KME20J2849

112482-5.0

KME22D1773

112482-7.5

19DT11

112482-2.5

KME20L1619

112482-5.0

KME22D3194

112482-7.5

19DT46

112482-2.5

KME20L1964

112482-5.0

KME22D3576

112482-7.5

19DT47

112482-2.5

KME20M0142

112482-5.0

KME22E0232

112482-7.5

19ET78

112482-2.5

KME20M2035

112482-5.5

18FG02

112482-7.5

19FT10

112482-2.5

KME20M3041

112482-5.5

18GG05

112482-7.5

19FT17

112482-2.5

KME20M3042

112482-5.5

18GT11

112482-7.5

19FT22

112482-2.5

KME21A2190

112482-5.5

18HG15

112482-7.5

19GT08

112482-2.5

KME21A2354

112482-5.5

18HG17

112482-7.5

20GT06

112482-2.5

KME21B0666

112482-5.5

19DT10

112482-7.5

20GT38

112482-2.5

KME21B0669

112482-5.5

19DT19

112482-7.5

KME20H1224

112482-2.5

KME21B1154

112482-5.5

19FT29

112482-7.5

KME20H1256

112482-2.5

KME21B1785

112482-5.5

20FT33

112482-7.5

KME20H1968

112482-2.5

KME21B2328

112482-5.5

20FT66

112482-7.5

KME20H1969

112482-2.5

KME21C0769

112482-5.5

20FT71

112482-7.5

KME20H2268

112482-2.5

KME21C1034

112482-5.5

20GT09

112482-7.5

KME20H2472

112482-2.5

KME22E0670

112482-5.5

20GT24

112482-7.5

KME20H2503

112482-2.5

KME22E2135

112482-5.5

KME20H2970

112482-7.5

KME20L0062

112482-3.0

18FG14

112482-5.5

KME20J1384

112482-7.5

KME21C2024

112482-3.0

18GG15

112482-5.5

KME20J2360

112482-7.5

KME21C2289

112482-3.0

18GG16

112482-5.5

KME20K0944

112482-7.5

KME21C2355

112482-3.0

19HT05

112482-5.5

KME21A0638

112482-7.5

KME21D0843

112482-3.0

19IT12

112482-5.5

KME21A1153

112482-7.5

KME21D1648

112482-3.0

19JT50

112482-5.5

KME21A1879

112482-7.5

KME21D1795

112482-3.0

19LT31

112482-5.5

KME21A2143

112482-7.5

KME21G1158

112482-3.0

20AT39

112482-5.5

KME21A2565

112482-7.5

KME21G1308

112482-3.0

20GT22

112482-5.5

KME21B2257

112482-7.5

KME21H0195

112482-3.0

KME20H1945

112482-5.5

KME21H0821

112482-7.5

KME21H0611

112482-3.0

KME20H2031

112482-5.5

KME21J1257

112482-7.5

KME21J0228

112482-3.0

KME20J0672

112482-5.5

KME21K1085

112482-7.5

KME21J0414

112482-3.0

KME20J1197

112482-5.5

KME21L1806

112482-7.5

KME21J1471

112482-3.0

KME20J1922

112482-5.5

KME21L1808

112482-7.5

KME21K0597

112482-3.0

KME20J3093

112482-5.5

KME21L1809

112482-7.5

KME21K0598

112482-3.0

KME20K0431

112482-5.5

KME21L2241

112482-7.5

KME21K1080

112482-3.0

KME20K1770

112482-5.5

KME21L2391

112482-7.5

KME21K2024

112482-3.0

KME20K2063

112482-6.0

18FG24

112482-7.5

KME21L0122

112482-3.0

KME20K2605

112482-6.0

18HG13

112482-7.5

KME21L0123

112482-3.0

KME20L0519

112482-6.0

18KG10

112482-7.5

KME21L0124

112482-3.0

KME21C0173

112482-6.0

19AT20

112482-7.5

KME21L0125

112482-3.0

KME21C0771

112482-6.0

19ET73

112482-7.5

KME21M1640

112482-3.0

KME21C0863

112482-6.0

19FT12

112482-7.5

KME22A2805

112482-3.0

KME21C1405

112482-6.0

19HT73

112482-8.0

18HT08

112482-3.0

KME22D0028

112482-6.0

19JT51

112482-8.0

18LT05

112482-3.0

KME22D1837

112482-6.0

19KT31

112482-8.0

18LT16

112482-3.0

KME22D2482

112482-6.0

20DT40

112482-8.0

19BG12

112482-3.0

KME22E1247

112482-6.0

20ET10

112482-8.0

19DT46

112482-3.5

18FG31

112482-6.0

KME20K3439

112482-8.0

19FT46

112482-3.5

18LG30

112482-6.0

KME20K3594

112482-8.0

19HT18

112482-3.5

19AG38

112482-6.0

KME20K3613

112482-8.0

19JT05

112482-3.5

19BG12

112482-6.0

KME20L1149

112482-8.0

19KT65

112482-3.5

19BG35

112482-6.0

KME21A1021

112482-8.0

19LT32

112482-3.5

19DT13

112482-6.0

KME21A1022

112482-8.0

20BT31

112482-3.5

19ET53

112482-6.0

KME21A2013

112482-8.0

20BT46

112482-3.5

19GT46

112482-6.0

KME21D2829

112482-8.0

20BT47

112482-3.5

19JT19

112482-6.0

KME21H0863

112482-8.0

20ET24

112482-3.5

19LT23

112482-6.0

KME21H0974

112482-8.0

20FT33

112482-3.5

20AT37

112482-6.0

KME21H1008

112482-8.0

20GT05

112482-3.5

20AT54

112482-6.0

KME21H1055

112482-8.0

20GT25

112482-3.5

20GT12

112482-6.0

KME21H1098

112482-8.0

KME20J0009

112482-3.5

KME20H0897

112482-6.0

KME21J1991

112482-8.0

KME20J2177

112482-3.5

KME20H1629

112482-6.0

KME21K0023

112482-8.0

KME20K2986

112482-3.5

KME20J0766

112482-6.0

KME21K2108

112482-8.0

KME20K3593

112482-3.5

KME20J0967

112482-6.0

KME21L0137

112482-8.0

KME21A2057

112482-3.5

KME20J0993

112482-6.0

KME21L0138

112482-8.0

KME21B2694

112482-3.5

KME20J1194

112482-6.0

KME21L1493

112482-8.0

KME21H0633

112482-3.5

KME20J1309

112482-6.0

KME21L1811

112482-8.0

KME21J1165

112482-3.5

KME20J1362

112482-6.0

KME21L2394

112482-8.0

KME21J1379

112482-3.5

KME20J2686

112482-6.0

KME21L2395

112482-8.0

KME21J1538

112482-3.5

KME20K0314

112482-6.0

KME21L2396

112482-8.0

KME21J1745

112482-3.5

KME20K2758

112482-6.0

KME21L2477

112482-8.0

KME21J1832

112482-3.5

KME20L0642

112482-6.0

KME22D1631

112482-8.0

KME21J1913

112482-3.5

KME21A2310

112482-6.0

KME22E0694

112482-8.0

KME21K2501

112482-3.5

KME21B0534

112482-6.0

KME22E2902

112482-8.0

KME21L2580

112482-3.5

KME21B2176

112482-6.5

18FG33

112482-8.0

KME22D3710

112482-3.5

KME21C0176

112482-6.5

18FT06

112482-8.0

KME22F0457

112482-3.5

KME21C1583

112482-6.5

18FT08

112482-8.0

KME22G0030

112482-3.5

KME21C2251

112482-6.5

18FT13

112482-8.5

KME22B0634

112482-3.5

KME21K2133

112482-6.5

18FT24

112482-8.5

KME22E0538

112482-3.5

KME21L2361

112482-6.5

18HT11

112482-8.5

KME22E0952

112482-3.5

KME21M1071

112482-6.5

18KG15

112482-8.5

KME22H0516

112482-3.5

KME22A0419

112482-6.5

18KG19

112482-8.5

KME22J2139

112482-3.5

KME22A2440

112482-6.5

18KG40

112482-8.5

KME22M0439

112482-3.5

KME22B0462

112482-6.5

18KG41

112482-9.5

19JT11

112482-3.5

KME22B0728

112482-6.5

18KT03

112482-9.5

KME20H1390