MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK, REF CDS840459R; 8) CAROTID-LF, REF CDS860039K; 9) CAROTID-LF, REF CDS860039L; 10) OPEN HEART ADULT KIT, REF CDS981319AD; 11) BAPTIST AAA, REF CDS982400M; 12) ZALE PUMP CDS, REF CDS983187G; 13) PEDIATRIC CARDIAC CDS-LF, REF CDS983481G; 14) MAJOR VASCULAR, REF CDS983489K; 15) CAROTID, REF CDS983495N; 16) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 17) AV FISTULA, REF CDS983638K; 18) PERIPHERAL VASCULAR CDS, REF CDS983723I; 19) ACH OPEN HEART, REF CDS983773J; 20) VASCULAR, REF CDS984255K; 21) VASCULAR CDS, REF CDS984275I; 22) OPEN HEART CDS, REF CDS984276O; 23) OPEN HEART CDS, REF CDS984355G; 24) OPEN HEART CDS, REF CDS984355I; 25) SMH VASCULAR CDS, REF CDS984584M; 26) VASCULAR CDS-LF, REF CDS984594G; 27) VASCULAR CDS-LF, REF CDS984594I; 28) VASCULAR, REF CDS985355F; 29) SJ BYPASS LEG CUSTOM PACK-LF, REF DYNJ0042944J; 30) SJ BYPS LEG CSTM PK RFID-LF, REF DYNJ0042944K; 31) AV FISTULA PACK-LF, REF DYNJ0131782G; 32) AV FISTULA PACK-LF, REF DYNJ0131782I; 33) AV FISTULA PACK-LF, REF DYNJ0131782J; 34) AV FISTULA PACK-LF, REF DYNJ0131782K; 35) VASCULAR PACK, REF DYNJ02467M; 36) OPEN HEART PACK A & B, REF DYNJ0283397U; 37) VASCULAR PACK-LF, REF DYNJ0421380P; 38) MAJOR VASCULAR PACK-LF, REF DYNJ0488546J; 39) SJ CARDIAC A PACK RFID-LF, REF DYNJ0619768M; 40) SJ PACEMAKER PACK RFID-LF, REF DYNJ0619848O; 41) PACEMAKER PACK-LF, REF DYNJ0826630N; 42) AV SHUNT PACK-LF, REF DYNJ0842516G; 43) GENERAL ENDO PACK-LF, REF DYNJ0842873K; 44) PACEMAKER PACK-LF, REF DYNJ0843217M; 45) PACEMAKER PACK-LF, REF DYNJ0843217N; 46) PACEMAKER PACK-LF, REF DYNJ0867353I; 47) PACEMAKER PACK-LF, REF DYNJ0867353J; 48) CAROTID ARTERY PACK-LF, REF DYNJ0882509L; 49) CAROTID ARTERY PACK-LF, REF DYNJ0882509N; 50) VASCULAR PACK-LF, REF DYNJ0901358J; 51) VASCULAR PACK-LF, REF DYNJ0901358K; 52) HEALTH ALL VASCULAR PACK-LF, REF DYNJ19538F; 53) OPEN HEART A&B PK-LF, REF DYNJ20888K; 54) OPEN HEART A&B PK-LF, REF DYNJ20888L; 55) GEN FEM POP #14-RF, REF DYNJ21877W; 56) CABG PACK A&B, REF DYNJ21971AD; 57) VASCULAR PACK, REF DYNJ22350L; 58) SVMMC CORE OPEN HEART PACK-LF, REF DYNJ22971T; 59) OPEN HEART SUPPLEMENT A, REF DYNJ24591AB; 60) SVMMC OPEN HEART ADD ON PACK, REF DYNJ24634O; 61) SVMMC PERMANENT PACING PACK, REF DYNJ24746I; 62) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 63) PACEMAKER PACK, REF DYNJ30928O; 64) VASCULAR PACK, REF DYNJ31902N; 65) DB CAROTID PACK-LF, REF DYNJ33579F; 66) DB ENDOVASCULAR AAA PACK-LF, REF DYNJ33689I; 67) PACEMAKER ICD PK, REF DYNJ34795K; 68) OPEN HEART PACK A&B, REF DYNJ35854D; 69) PACEMAKER PACK, REF DYNJ36025D; 70) RRMC PACEMAKER PACK, REF DYNJ36337G; 71) OPEN HEART PACK, REF DYNJ37284J; 72) PACEMAKER PACK, REF DYNJ37557D; 73) PEDIATRIC CARDIAC MINOR, REF DYNJ37618D; 74) ACH CABG ADD-ON, REF DYNJ38175L; 75) PACEMAKER SET UP PACK, REF DYNJ38232B; 76) PACEMAKER PACK-LF, REF DYNJ38643F; 77) PACEMAKER PACK-LF, REF DYNJ38702A; 78) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439K; 79) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439L; 80) CARDIOVASCULAR PACK, REF DYNJ42921G; 81) CABG PACK-LF, REF DYNJ43207K; 82) HEART DRAPING PACK-LF, REF DYNJ43214F; 83) VASCULAR PACK, REF DYNJ43276I; 84) SVMMC VASCULAR MAJOR PACK, REF DYNJ43777J; 85) OPEN HEART PACK A AND B, REF DYNJ43858B; 86) SVMMC CAROTID PACK, REF DYNJ43861F; 87) MAJOR VASCULAR PACK, REF DYNJ44161G; 88) MINOR VASCULAR PACK, REF DYNJ44164F; 89) VASCULAR ACCESS PACK, REF DYNJ44172D; 90) AV FISTULA PACK, REF DYNJ44704J; 91) AAA PACK, REF DYNJ44847I; 92) CARDIAC VASCULAR PACK, REF DYNJ44854M; 93) CASTRO CABG-COMPONENT PACK, REF DYNJ44857S; 94) CASTRO CABG-COMPONENT PACK, REF DYNJ44857T; 95) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 96) FIST

Detalles del retiro

Fabricante

MEDLINE INDUSTRIES, LP - Northfield

Distribuidor

US Nationwide distribution.

Lote

1) REF CDS840232L, UDI/DI 10195327013691 (each) 40195327013692 (case), Lot Numbers: 22FBF374, 22FBX255, 23EBQ492, 23CBW366, 23CBW387, 23IBS976; 2) REF CDS840233I, UDI/DI 10195327065270 (each) 40195327065271 (case), Lot Numbers: 22GBJ144, 22FBO691, 22HBS387, 23BBG362, 23DBD583, 23GBU961, 23GBU784; 3) REF CDS840261AB, UDI/DI 10195327104535 (each) 40195327104536 (case), Lot Numbers: 22FBX514, 22IBE745, 23ABG192, 22KBO918, 23DBE827; 4) REF CDS840387T, UDI/DI 10195327070946 (each) 40195327070947 (case), Lot Numbers: 22FBS963, 22HBO062; 5) REF CDS840402AF, UDI/DI 10195327144029 (each) 40195327144020 (case), Lot Numbers: 22ELB107, 22ELA850, 22FLA766; 6) REF CDS840402AI, UDI/DI 10195327334024 (each) 40195327334025 (case), Lot Numbers: 23DLA845, 23GLA701, 23GLA627, 23HLA275, 23LLA792; 7) REF CDS840459R, UDI/DI 10195327194598 (each) 40195327194599 (case), Lot Numbers: 22HBR722, 23IBD831, 23IBD869, 23JBR310; 8) REF CDS860039K, UDI/DI 10195327009397 (each) 40195327009398 (case), Lot Numbers: 22FBF456, 23ABP502, 23DBE091, 23HBU269; 9) REF CDS860039L, UDI/DI 10195327533281 (each) 40195327533282 (case), Lot Numbers: 23KBT206; 10) REF CDS981319AD, UDI/DI 10195327547226 (each) 40195327547227 (case), Lot Numbers: 24AMI772; 11) REF CDS982400M, UDI/DI 10195327034566 (each) 40195327034567 (case), Lot Numbers: 23JBB859, 23KBT042, 24CBH306; 12) REF CDS983187G, UDI/DI 10195327258528 (each) 40195327258529 (case), Lot Numbers: 23EBK193, 23BBN996, 23BBN811, 23ABC476, 23EBG037; 13) REF CDS983481G, UDI/DI 10195327497347 (each) 40195327497348 (case), Lot Numbers: 23LDA076, 23KDC290, 24BDA534, 24DDA867; 14) REF CDS983489K, UDI/DI 10195327497279 (each) 40195327497270 (case), Lot Numbers: 24ADA159; 15) REF CDS983495N, UDI/DI 10195327497323 (each) 40195327497324 (case), Lot Numbers: 23KDB048, 24ADB582; 16) REF CDS983637I, UDI/DI 10195327228125 (each) 40195327228126 (case), Lot Numbers: 22LBC194, 22KBC672, 23ABM692; 17) REF CDS983638K, UDI/DI 10195327228132 (each) 40195327228133 (case), Lot Numbers: 22LBE872, 22KBN596, 23BBR976, 23ABE312, 23ABH461, 23CBS006; 18) REF CDS983723I, UDI/DI 10195327228156 (each) 40195327228157 (case), Lot Numbers: 22JBR360, 22IBP608; 19) REF CDS983773J, UDI/DI 10195327233617 (each) 40195327233618 (case), Lot Numbers: 22JBH775, 23GBD523, 23ABM749, 22LBF067; 20) REF CDS984255K, UDI/DI 10193489288605 (each) 40193489288606 (case), Lot Numbers: 23CBK162, 22EBR558, 22EBL560, 22DBJ679, 23ABA809, 23DBN450, 23FBV267; 21) REF CDS984275I, UDI/DI 10195327291495 (each) 40195327291496 (case), Lot Numbers: 23DMI544, 23CMB945, 23BMC994; 22) REF CDS984276O, UDI/DI 10195327291501 (each) 40195327291502 (case), Lot Numbers: 23EME524, 23DMB942, 23CMB933; 23) REF CDS984355G, UDI/DI 10193489484632 (each) 40193489484633 (case), Lot Numbers: 22FLA187, 22ILA721, 22JLB146, 23CLA569, 23CLA762, 22LLA693, 22LLA544, 23JLA617, 23ILB099, 23HLA237, 23LLA067; 24) REF CDS984355I, UDI/DI 10195327569518 (each) 40195327569519 (case), Lot Numbers: 24BLA231, 24ELA326; 25) REF CDS984584M, UDI/DI 10195327103408 (each) 40195327103409 (case), Lot Numbers: 22LBB056, 22LBS784; 26) REF CDS984594G, UDI/DI 10193489486018 (each) 40193489486019 (case), Lot Numbers: 22KMH611, 23BMF522, 23BMA884, 22LME007, 23KMJ522; 27) REF CDS984594I, UDI/DI 10195327569648 (each) 40195327569649 (case), Lot Numbers: 24FMA273; 28) REF CDS985355F, UDI/DI 10195327242626 (each) 40195327242627 (case), Lot Numbers: 22JDB190, 23HDA552, 23KDA009, 23LDA593, 24BDA354, 23ADB630, 23EDA925, 24DDB955; 29) REF DYNJ0042944J, UDI/DI 10195327295837 (each) 40195327295838 (case), Lot Numbers: 23AMA477; 30) REF DYNJ0042944K, UDI/DI 10195327332976 (each) 40195327332977 (case), Lot Numbers: 23IBQ877, 23KBI390; 31) REF DYNJ0131782G, UDI/DI 10195327124571 (each) 40195327124572 (case), Lot Numbers: 22FMD014; 32) REF DYNJ0131782I, UDI/DI 10195327216337 (each) 40195327216338 (case), Lot Numbers: 22HMD256, 22LMF877, 23CMG748, 23EMG239; 3

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States