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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1389-2024

Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON'S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002

Publicado el 3 de abril de 2024 · Inicio del retiro: 30 de enero de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Applied Medical Resources Corp
Distribuidor
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Venezuela.
Lote
Reference Number/Lot Number/UDI Number: GK1003, AME KIT 54562 1493930 (01)20607915144979(17)250911(30)01(10)1493930 GK1003, AME KIT 54562 1499051 (01)20607915144979(17)251030(30)01(10)1499051 GK1003, AME KIT 54562 1505559 (01)20607915144979(17)251030(30)01(10)1505559 GK1003, AME KIT 54562 1509312 (01)20607915144979(17)260116(30)01(10)1509312 GK1003, AME KIT 54562 1510944 (01)20607915144979(17)260327(30)01(10)1510944 GK1004, KIT LAP CHOL DEN HOED 2 1498012 (01)20607915144993(17)251106(30)01(10)1498012 GK1004, KIT LAP CHOL DEN HOED 2 1498814 (01)20607915144993(17)251106(30)01(10)1498814 GK1004, KIT LAP CHOL DEN HOED 2 1507422 (01)20607915144993(17)250420(30)01(10)1507422 GK1004, KIT LAP CHOL DEN HOED 2 1510192 (01)20607915144993(17)260403(30)01(10)1510192 GK1005, K2550 - H¿PATECTOMIE ERASME 1503416 (01)20607915145006(17)251102(30)01(10)1503416 GK1011, K-19459 1492258 (01)20607915145136(17)240908(30)01(10)1492258 GK1011, K-19459 1494291 (01)20607915145136(17)240908(30)01(10)1494291 GK1011, K-19459 1496830 (01)20607915145136(17)240908(30)01(10)1496830 GK1011, K-19459 1501491 (01)20607915145136(17)240908(30)01(10)1501491 GK1011, K-19459 1503409 (01)20607915145136(17)241110(30)01(10)1503409 GK1011, K-19459 1505119 (01)20607915145136(17)241003(30)01(10)1505119 GK1011, K-19459 1506824 (01)20607915145136(17)250804(30)01(10)1506824 GK1011, K-19459 1509999 (01)20607915145136(17)250804(30)01(10)1509999 GK1011, K-19459 1512086 (01)20607915145136(17)260202(30)01(10)1512086 GK1014, K-18031 STANDARD KIT 1492615 (01)20607915145112(17)250821(30)01(10)1492615 GK1014, K-18031 STANDARD KIT 1498019 (01)20607915145112(17)251106(30)01(10)1498019 GK1014, K-18031 STANDARD KIT 1500346 (01)20607915145112(17)260205(30)01(10)1500346 GK1018, K-20735 STANDARD KIT 1490830 (01)20607915145211(17)250821(30)01(10)1490830 GK1018, K-20735 STANDARD KIT 1493458 (01)20607915145211(17)250307(30)01(10)1493458 GK1018, K-20735 STANDARD KIT 1493663 (01)20607915145211(17)250911(30)01(10)1493663 GK1018, K-20735 STANDARD KIT 1496834 (01)20607915145211(17)250321(30)01(10)1496834 GK1018, K-20735 STANDARD KIT 1499821 (01)20607915145211(17)260319(30)01(10)1499821 GK1018, K-20735 STANDARD KIT 1504146 (01)20607915145211(17)260205(30)01(10)1504146 GK1018, K-20735 STANDARD KIT 1504513 (01)20607915145211(17)260205(30)01(10)1504513 GK1018, K-20735 STANDARD KIT 1507714 (01)20607915145211(17)251214(30)01(10)1507714 GK1018, K-20735 STANDARD KIT 1509639 (01)20607915145211(17)260524(30)01(10)1509639 GK1018, K-20735 STANDARD KIT 1512094 (01)20607915145211(17)260522(30)01(10)1512094 GK1018, K-20735 STANDARD KIT 1512095 (01)20607915145211(17)260522(30)01(10)1512095 GK1033, AME STANDARD KIT 21-023 1490821 (01)20607915145648(17)251221(30)01(10)1490821 GK1033, AME STANDARD KIT 21-023 1490903 (01)20607915145648(17)251221(30)01(10)1490903 GK1033, AME STANDARD KIT 21-023 1491315 (01)20607915145648(17)251221(30)01(10)1491315 GK1033, AME STANDARD KIT 21-023 1491731 (01)20607915145648(17)251212(30)01(10)1491731 GK1033, AME STANDARD KIT 21-023 1493162 (01)20607915145648(17)251221(30)01(10)1493162 GK1033, AME STANDARD KIT 21-023 1495246 (01)20607915145648(17)260201(30)01(10)1495246 GK1033, AME STANDARD KIT 21-023 1497709 (01)20607915145648(17)250410(30)01(10)1497709 GK1033, AME STANDARD KIT 21-023 1498010 (01)20607915145648(17)260201(30)01(10)1498010 GK1033, AME STANDARD KIT 21-023 1498633 (01)20607915145648(17)260305(30)01(10)1498633 GK1033, AME STANDARD KIT 21-023 1500231 (01)20607915145648(17)260321(30)01(10)1500231 GK1033, AME STANDARD KIT 21-023 1501062 (01)20607915145648(17)260321(30)01(10)1501062 GK1033, AME STANDARD KIT 21-023 1503405 (01)20607915145648(17)260425(30)01(10)1503405 GK1033, AME STANDARD KIT 21-023 1504625 (01)20607915145648(17)260425(30)01(10)1504625 GK1033, AME STANDARD KIT 21-023 1505118 (01)20607915145648(17)241212(30)01(10)1505118 GK1033, AME STANDARD KIT 21-023 1505796 (01)20607915145648(17)260425(30)01(10)1505796 GK1033, AME STANDARD KIT 21-023 1507783 (01)20607915145648(17)26
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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