Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Number SPEC0004C; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 10) BIOPSY BASIC PACK, Pack Number P784604; 11) BIOPSY KIT, Pack Number DYNDA1466A; 12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 13) BIOPSY TRAY, Pack Number BT1015; 14) BIOPSY TRAY, Pack Number DYNDH1273; 15) BIOPSY TRAY, Pack Number BT1060; 16) BIOPSY TRAY, Pack Number DYNDH1340; 17) BIOPSY TRAY, Pack Number P151659; 18) BIOPSY TRAY, Pack Number SPEC0292; 19) BIOPSY TRAY, Pack Number DYNDH1314A; 20) BIOPSY TRAY, Pack Number DYNDH1137C; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) BIOPSY TRAY-LF, Pack Number SPEC4380; 23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 25) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 26) CATHETER ON/OFF KIT, Pack Number DT5490B; 27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 28) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 31) CIRCUMCISION TRAY, Pack Number CIT6260; 32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 34) CORE BIOPSY TRAY, Pack Number SPEC0083B; 35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 36) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 37) CUSTOM BX TRAY, Pack Number SPEC0071B; 38) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 39) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 40) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 41) ER CHEST TUBE TRAY, Pack Number CHT1570A; 42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952; 43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421; 44) FINE LACERATION KIT, Pack Number SUT19360; 45) FINE LACERATION KIT, Pack Number SUT17215; 46) HH PACK BIOPSY, Pack Number BT345; 47) HSG TRAY, Pack Number DYNDH1453; 48) I&D TRAY, Pack Number ID2165; 49) INCISION & DRAINAGE TRAY, Pack Number ID2060; 50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 53) LACERATION TRAY, Pack Number SUT20955; 54) LACERATION TRAY, Pack Number DYNDL1772; 55) LACERATION TRAY, Pack Number DYNDL1250C; 56) LACERATION TRAY, Pack Number DYNDL1887; 57) LACERATION TRAY, Pack Number SUT3780; 58) LACERATION TRAY, Pack Number DYNDL1774A; 59) LACERATION TRAY, Pack Number SUT18080; 60) LACERATION TRAY, Pack Number SUT21490; 61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 65) LUMBAR PUNCTURE TRAY, Pack Number PT215; 66) LUMBAR TRAY, Pack Number SPEC0177; 67) LUMBAR TRAY, Pack Number DYNDH1540A; 68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324; 70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A; 71) MYELOGRAM TRAY, Pack Number DYNJTS0516A; 72) MYELOGRAM TRAY, Pack Number DYNJTS0514; 73) MYELOGRAM TRAY, Pack Number DYNDH1531; 74) OB DELIVERY SET, Pack Number MNS3355; 75) OB DELIVERY TRAY, Pack Number MNS5575; 76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 78) PACEMAKER TRAY, Pack Number MNS12700; 79) PACEMAKER TRAY, Pack Number MNS12625; 80) PACEMAKER TRAY, Pack Number MNS12700A; 81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B; 82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 83)

Detalles del retiro

Fabricante

MEDLINE INDUSTRIES, LP - Northfield

Distribuidor

worldwide

Lote

ART240B, Lot Number 2023083190; PICC0020, Lot Number 2023122290; ART245B, Lot Number 2023020990; ART245B, Lot Number 2023071090; SUT15940, Lot Number 2021070290; SUT15940, Lot Number 2022090190; SUT15940, Lot Number 2022092690; SPEC0004C, Lot Number 2019042990; DYNDH1134, Lot Number 2020032050; SPEC0400, Lot Number 2021120990; SPEC0400, Lot Number 2022090190; SPEC0400, Lot Number 2023050390; PT220, Lot Number 2018082290; PT220, Lot Number 2020040890; PT220, Lot Number 2020051490; PT220, Lot Number 2020061090; PT220, Lot Number 2020071590; PT220, Lot Number 2020122190; PT220, Lot Number 2021040790; PT220, Lot Number 2021050390; PT220, Lot Number 2021080690; PT220, Lot Number 2021082790; PT220, Lot Number 2021100690; PT220, Lot Number 2022082490; PT220, Lot Number 2023030290; PT220, Lot Number 2023110690; PT220, Lot Number 2023122290; PT220, Lot Number 2024031190; CHT500, Lot Number 2021113090; CHT500, Lot Number 2021121690; CHT500, Lot Number 2022050390; CHT500, Lot Number 2023060190; CHT500, Lot Number 2023070390; CHT500, Lot Number 2023092290; P784604, Lot Number 2019081980; DYNDA1466A, Lot Number 2022092690; SUT20455, Lot Number 2018090690; SUT20455, Lot Number 2019022590; SUT20455, Lot Number 2019042990; SUT20455, Lot Number 2019101690; SUT20455, Lot Number 2019112590; SUT20455, Lot Number 2020040690; SUT20455, Lot Number 2021042190; SUT20455, Lot Number 2021062590; SUT20455, Lot Number 2021081090; SUT20455, Lot Number 2022070590; SUT20455, Lot Number 2023070590; SUT20455, Lot Number 2023100590; SUT20455, Lot Number 2023122990; BT1015, Lot Number 2019013190; DYNDH1273, Lot Number 2019080190; BT1060, Lot Number 2019091090; DYNDH1340, Lot Number 2019100190; BT1060, Lot Number 2019103190; P151659, Lot Number 2019112590; DYNDH1340, Lot Number 2019121290; SPEC0292, Lot Number 2020012290; BT1015, Lot Number 2020082490; BT1060, Lot Number 2020082890; DYNDH1314A, Lot Number 2020100901; BT1015, Lot Number 2020102990; DYNDH1137C, Lot Number 2020102990; BT1015, Lot Number 2021010590; BT1015, Lot Number 2021032590; BT1015, Lot Number 2021050390; BT1015, Lot Number 2021070690; BT1015, Lot Number 2021100490; BT1015, Lot Number 2022021890; BT1015, Lot Number 2022102490; BT1015, Lot Number 2023013090; BT1015, Lot Number 2023040490; BT1015, Lot Number 2023060990; DYNJTS0018A, Lot Number 2020010850; DYNJTS0018A, Lot Number 2022050390; SPEC4380, Lot Number 2021120990; SPEC4380, Lot Number 2022032290; SPEC4380, Lot Number 2022060890; DYNDH1115, Lot Number 2019080190; DYNJTS0214, Lot Number 2022051790; DYNJTS0214, Lot Number 2023112890; SPEC0130C, Lot Number 2020082490; SPEC0130C, Lot Number 2021102790; DT5490B, Lot Number 2022121490; S5078BF09, Lot Number 2021031650; CHT705, Lot Number 2019121290; CHT705, Lot Number 2019121990; CHT705, Lot Number 2020021890; CHT705, Lot Number 2020040690; CHT705, Lot Number 2021080690; CHT1900, Lot Number 2022040590; CHT705, Lot Number 2022092690; CHT1900, Lot Number 2022110890; DYNDA1432A, Lot Number 2019100190; CIT6260, Lot Number 2020100901; CIT6260, Lot Number 2022011190; CIT6260, Lot Number 2022060890; CIT6260, Lot Number 2022072290; CIT6785A, Lot Number 2020081090; CIT6785A, Lot Number 2021022390; CIT6785A, Lot Number 2021032590; DYNDA2213A, Lot Number 2019081980; SPEC0083B, Lot Number 2022072190; SPEC0083B, Lot Number 2023050390; DYNJ05162, Lot Number 2022022390; MNS4815, Lot Number 2021100590; MNS4815, Lot Number 2021122890; MNS4815, Lot Number 2023011390; MNS4815, Lot Number 2023012090; MNS4815, Lot Number 2023061590; SPEC0071B, Lot Number 2019022590; MNS6496, Lot Number 2019022590; MNS6496, Lot Number 2023062990; DYNDH1359, Lot Number 2019022590; DYNDH1359, Lot Number 2019040290; DYNDH1359, Lot Number 2019100190; DYNDH1359, Lot Number 2020072290; DYNDH1359, Lot Number 2020091490; DYNDH1359, Lot Number 2021021990; DYNDH1359, Lot Number 2021031290; DYNDH1359, Lot Number 2021042290; DY

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States