Class 2 Device Recall Medline

• Date Initiated by Firm: October 09, 2024
• Date Posted: December 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0625-2025
• Recall Event ID: 95621
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: 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
• Code Information: 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; 33) REF DYNJ0131782J, UDI/DI 10195327467548 (each) 40195327467549 (case), Lot Numbers: 23JMB245, 23LMD975, 23LMD975A, 24CMB321; 34) REF DYNJ0131782K, UDI/DI 10198459004100 (each) 40198459004101 (case), Lot Numbers: 24DMJ721; 35) REF DYNJ02467M, UDI/DI 10195327267063 (each) 40195327267064 (case), Lot Numbers: 23HDA596, 23JDA202, 23BDB849; 36) REF DYNJ0283397U, UDI/DI 10195327083663 (each) 40195327083664 (case), Lot Numbers: 22FLA772, 23CMG750, 23AMH830, 23FMD705; 37) REF DYNJ0421380P, UDI/DI 10195327084271 (each) 40195327084272 (case), Lot Numbers: 22DMI805, 22FMH642, 22HME900, 22LMF893, 23EMF197; 38) REF DYNJ0488546J, UDI/DI 10195327046071 (each) 40195327046072 (case), Lot Numbers: 22EBM773, 22GBA204, 23FBB049, 23CBS596, 23BBH640; 39) REF DYNJ0619768M, UDI/DI 10195327332990 (each) 40195327332991 (case), Lot Numbers: 23AMG464, 23JBR034; 40) REF DYNJ0619848O, UDI/DI 10195327333027 (each) 40195327333028 (case), Lot Numbers: 23JBH173, 23GBL340, 23IBQ228; 41) REF DYNJ0826630N, UDI/DI 10195327415716 (each) 40195327415717 (case), Lot Numbers: 23EME511, 23HMH788; 42) REF DYNJ0842516G, UDI/DI 10195327286392 (each) 40195327286393 (case), Lot Numbers: 23JDA626, 23DDB550; 43) REF DYNJ0842873K, UDI/DI 10195327286613 (each) 40195327286614 (case), Lot Numbers: 23CDA339, 23ADA210, 23EDB190, 23IDC327, 24DDB511, 23HDA476; 44) REF DYNJ0843217M, UDI/DI 10195327286309 (each) 40195327286300 (case), Lot Numbers: 23EDB125; 45) REF DYNJ0843217N, UDI/DI 10195327522209 (each) 40195327522200 (case), Lot Numbers: 23JDA492; 46) REF DYNJ0867353I, UDI/DI 10195327014025 (each) 40195327014026 (case), Lot Numbers: 22DMG592; 47) REF DYNJ0867353J, UDI/DI 10195327211004 (each) 40195327211005 (case), Lot Numbers: 23CDC666, 23EDB881, 23HDB832, 23HDB625; 48) REF DYNJ0882509L, UDI/DI 10195327124854 (each) 40195327124855 (case), Lot Numbers: 22DDB150, 22EDB892; 49) REF DYNJ0882509N, UDI/DI 10195327467593 (each) 40195327467594 (case), Lot Numbers: 23HDA299, 23JDA115, 24BDA761, 24DDB706; 50) REF DYNJ0901358J, UDI/DI 10195327156558 (each) 40195327156559 (case), Lot Numbers: 22EDA673; 51) REF DYNJ0901358K, UDI/DI 10195327343224 (each) 40195327343225 (case), Lot Numbers: 22EDA673, 22EDA673; 52) REF DYNJ19538F, UDI/DI 10195327658137 (each) 40195327658138 (case), Lot Numbers: 24CBR265, 24DBC271, 24EBA248; 53) REF DYNJ20888K, UDI/DI 10195327360122 (each) 40195327360123 (case), Lot Numbers: 23JMB635; 54) REF DYNJ20888L, UDI/DI 10195327526559 (each) 40195327526550 (case), Lot Numbers: 24FMJ017, 24CMG240, 24CMG240A; 55) REF DYNJ21877W, UDI/DI 10195327104542 (each) 40195327104543 (case), Lot Numbers: 22HBY576, 22GBJ538, 22FBX857, 22FBX859, 23BBM525, 23BBL606; 56) REF DYNJ21971AD, UDI/DI 10195327227050 (each) 40195327227051 (case), Lot Numbers: 23IDA269, 23CDC715, 23HDB096, 23FDC297, 23FDA779; 57) REF DYNJ22350L, UDI/DI 10193489445251 (each) 40193489445252 (case), Lot Numbers: 23ABI883, 22FBW311, 23FBH667, 23FBH408; 58) REF DYNJ22971T, UDI/DI 10195327136833 (each) 40195327136834 (case), Lot Numbers: 23DBM601, 22LBO452, 23ABR900, 23CBW859, 23FBE213, 23HBT033, 24CBE262, 23KBK076, 24BBK319, 24DBH817, 24EBA155; 59) REF DYNJ24591AB, UDI/DI 10195327658151 (each) 40195327658152 (case), Lot Numbers: 24DBD018; 60) REF DYNJ24634O, UDI/DI 10193489981933 (each) 40193489981934 (case), Lot Numbers: 22JBY664, 23HBP209, 23GBM805, 23ABI848, 24BBN420, 24CBH899; 61) REF DYNJ24746I, UDI/DI 10193489981964 (each) 40193489981965 (case), Lot Numbers: 23BBP012, 22EBV149, 22JBG824, 23IBU661, 23LBN730, 23CBJ655, 24BBJ405, 23BBA539, 23DBB005, 24CBK847, 24CBH934, 24CBA678, 23JBJ727, 23HBX614, 24DBU652; 62) REF DYNJ27432AC, UDI/DI 10195327104511 (each) 40195327104512 (case), Lot Numbers: 22FBW738, 22FBM446, 22HBQ892, 22LBL474, 23BBL659, 23BBA188, 23CBS798, 23DBR552; 63) REF DYNJ30928O, UDI/DI 10195327546236 (each) 40195327546237 (case), Lot Numbers: 23KMD845; 64) REF DYNJ31902N, UDI/DI 10195327491628 (each) 40195327491629 (case), Lot Numbers: 23JBP390; 65) REF DYNJ33579F, UDI/DI 10195327469627 (each) 40195327469628 (case), Lot Numbers: 23GDB693, 23JDA476; 66) REF DYNJ33689I, UDI/DI 10195327469634 (each) 40195327469635 (case), Lot Numbers: 23JDA119, 23HDA469, 23GDB709; 67) REF DYNJ34795K, UDI/DI 10195327006297 (each) 40195327006298 (case), Lot Numbers: 22EBL968, 23BBI869, 22KBM200, 22JBO258, 22FBQ048, 23IBI784, 23HBB861, 23KBM718, 23JBT741, 22KBQ237, 24BBO125, 23CBW712, 23EBF153, 23GBK896, 23FBA285, 24EBD876; 68) REF DYNJ35854D, UDI/DI 10195327053758 (each) 40195327053759 (case), Lot Numbers: 22FBC844, 22JBM658, 23KBO432, 23GBH041; 69) REF DYNJ36025D, UDI/DI 10195327527044 (each) 40195327527045 (case), Lot Numbers: 23JMJ922, 23KME711; 70) REF DYNJ36337G, UDI/DI 10195327354770 (each) 40195327354771 (case), Lot Numbers: 23KMJ118, 23HME890; 71) REF DYNJ37284J, UDI/DI 10193489873924 (each) 40193489873925 (case), Lot Numbers: 22KBM165, 23ABA989, 23BBG022; 72) REF DYNJ37557D, UDI/DI 10195327497330 (each) 40195327497331 (case), Lot Numbers: 23IDB874, 23KDA219, 24ADC093, 23LDB943, 24CDA516; 73) REF DYNJ37618D, UDI/DI 10195327497354 (each) 40195327497355 (case), Lot Numbers: 24CDA258, 24DDA575; 74) REF DYNJ38175L, UDI/DI 10195327227906 (each) 40195327227907 (case), Lot Numbers: 23DLA757, 23FLA915; 75) REF DYNJ38232B, UDI/DI 10195327381516 (each) 40195327381517 (case), Lot Numbers: 23IBT691, 23JBS179; 76) REF DYNJ38643F, UDI/DI 10195327227937 (each) 40195327227938 (case), Lot Numbers: 22HBQ912; 77) REF DYNJ38702A, UDI/DI 10195327457624 (each) 40195327457625 (case), Lot Numbers: 23GDB758, 23JDA281; 78) REF DYNJ39439K, UDI/DI 10195327362393 (each) 40195327362394 (case), Lot Numbers: 23CMD872, 23HMH139, 23HMA898; 79) REF DYNJ39439L, UDI/DI 10195327526634 (each) 40195327526635 (case), Lot Numbers: 23JMI397, 24DMH989, 24AME070; 80) REF DYNJ42921G, UDI/DI 10193489981384 (each) 40193489981385 (case), Lot Numbers: 22EBB834, 22GBP119, 22LBS108, 22HBE411, 22FBR416, 22JBO411, 22KBO777, 23CBD572; 81) REF DYNJ43207K, UDI/DI 10193489952926 (each) 40193489952927 (case), Lot Numbers: 22FMI228, 22EMF236, 22FMH513, 22LMC314, 22HMF871, 23EME962; 82) REF DYNJ43214F, UDI/DI 10193489953077 (each) 40193489953078 (case), Lot Numbers: 22FMB105, 22IMC155, 22FMI229, 23AMA058, 23CMG602; 83) REF DYNJ43276I, UDI/DI 10195327324803 (each) 40195327324804 (case), Lot Numbers: 23ABS475, 23BBB912; 84) REF DYNJ43777J, UDI/DI 10193489990188 (each) 40193489990189 (case), Lot Numbers: 23CBV816, 22EBT672, 23FBE221, 22LBL106, 22JBJ507, 22IBV692, 23ABJ286, 23KBK082, 23LBJ800, 24BBS028, 24ABI937, 23GBJ232, 23EBF689, 24CBD080; 85) REF DYNJ43858B, UDI/DI 10195327200190 (each) 40195327200191 (case), Lot Numbers: 23ABO442, 22LBS452, 23CBF269, 23FBF962, 23GBS094; 86) REF DYNJ43861F, UDI/DI 10193489981643 (each) 40193489981644 (case), Lot Numbers: 23ABG948, 22LBJ165, 22JBL517, 23DBP913, 23CBM958, 23GBH240, 24BBL675, 24ABN818, 24BBC635, 24DBJ612; 87) REF DYNJ44161G, UDI/DI 10195327412913 (each) 40195327412914 (case), Lot Numbers: 23FBQ167, 23EBV410, 23HBK287, 23IBT040; 88) REF DYNJ44164F, UDI/DI 10195327412944 (each) 40195327412945 (case), Lot Numbers: 23EBO910, 23IBJ743, 23JBV574; 89) REF DYNJ44172D, UDI/DI 10195327413071 (each) 40195327413072 (case), Lot Numbers: 23FBA073, 23IBM001; 90) REF DYNJ44704J, UDI/DI 10195327277437 (each) 40195327277438 (case), Lot Numbers: 23HDA797; 91) REF DYNJ44847I, UDI/DI 10195327127558 (each) 40195327127559 (case), Lot Numbers: 22DLA734, 22GLB033, 22ILA155, 23DLA101, 23CLA032, 23BLA770; 92) REF DYNJ44854M, UDI/DI 10195327298050 (each) 40195327298051 (case), Lot Numbers: 23BMC107; 93) REF DYNJ44857S, UDI/DI 10195327127602 (each) 40195327127603 (case), Lot Numbers: 22FBX138; 94) REF DYNJ44857T, UDI/DI 10195327221959 (each) 40195327221950 (case), Lot Numbers: 22JBD481, 22JBD481Z; 95) REF DYNJ44857U, UDI/DI 10195327298067 (each) 40195327298068 (case), Lot Numbers: 23CBE783; 96) REF DYNJ44869K, UDI/DI 10195327127657 (each) 40195327127658 (case), Lot Numbers: 22LMF304, 22GMA241, 22LMB852, 23DMF821; 97) REF DYNJ44879J, UDI/DI 10195327127718 (each) 40195327127719 (case), Lot Numbers: 22FBM843, 22FBM848, 22JBN378; 98) REF DYNJ44879K, UDI/DI 10195327282233 (each) 40195327282234 (case), Lot Numbers: 22LBI336, 22LBI111, 22LBI116, 22LBI120; 99) REF DYNJ44886M, UDI/DI 10195327127749 (each) 40195327127740 (case), Lot Numbers: 22KBU658, 22IBI902, 22HBG761, 22GBH771, 22EBR111, 22EBG860, 22JBO222, 23CBE998, 23DBN895; 100) REF DYNJ44890G, UDI/DI 10195327298449 (each) 40195327298440 (case), Lot Numbers: 22LDB092; 101) REF DYNJ46372M, UDI/DI 10195327239831 (each) 40195327239832 (case), Lot Numbers: 23BMG550; 102) REF DYNJ47940D, UDI/DI 10195327265205 (each) 40195327265206 (case), Lot Numbers: 23AMF399, 23BMB239; 103) REF DYNJ47940F, UDI/DI 10195327381356 (each) 40195327381357 (case), Lot Numbers: 23FMA616; 104) REF DYNJ47940I, UDI/DI 10195327514747 (each) 40195327514748 (case), Lot Numbers: 23JME664, 23LMC257, 24AMI513, 24DMC850; 105) REF DYNJ48153F, UDI/DI 10193489989694 (each) 40193489989695 (case), Lot Numbers: 23CBV817, 23EBD217, 23DBO375, 23KBX869, 23KBD333, 23GBH302, 24BBA166, 24DBV439, 24CBK849; 106) REF DYNJ48943C, UDI/DI 10195327186470 (each) 40195327186471 (case), Lot Numbers: 22FBW028; 107) REF DYNJ49801I, UDI/DI 10195327143923 (each) 40195327143924 (case), Lot Numbers: 22DBJ173, 23CBJ483, 23CBF195, 23BBK535, 23DBE726; 108) REF DYNJ50528M, UDI/DI 10195327129699 (each) 40195327129690 (case), Lot Numbers: 22EBM700, 22HBX666, 22LBO713, 23EBA780; 109) REF DYNJ51038Q, UDI/DI 10195327174071 (each) 40195327174072 (case), Lot Numbers: 22EBV529, 22JBI155; 110) REF DYNJ51038R, UDI/DI 10195327298258 (each) 40195327298259 (case), Lot Numbers: 22LBQ662; 111) REF DYNJ52140G, UDI/DI 10195327222871 (each) 40195327222872 (case), Lot Numbers: 22KDA259, 23DDA889, 23CDB276, 23HDB567, 23FDC085, 23JDA854, 24CDA708; 112) REF DYNJ52414I, UDI/DI 10195327339227 (each) 40195327339228 (case), Lot Numbers: 23EDC164, 23DDA268, 23HDB076, 23GDB441, 23IDA305; 113) REF DYNJ53427J, UDI/DI 10195327339449 (each) 40195327339440 (case), Lot Numbers: 23DDA946, 23IDC130, 23JDA038; 114) REF DYNJ53428M, UDI/DI 10195327339456 (each) 40195327339457 (case), Lot Numbers: 23GDB507; 115) REF DYNJ53430L, UDI/DI 10195327339470 (each) 40195327339471 (case), Lot Numbers: 23CDA196, 23FDB009, 23GDB001; 116) REF DYNJ53433K, UDI/DI 10195327339487 (each) 40195327339488 (case), Lot Numbers: 23DDA598, 23EDC014, 23GDB117, 23HDA665, 23JDA690; 117) REF DYNJ53527D, UDI/DI 10195327286576 (each) 40195327286577 (case), Lot Numbers: 23GDB023, 23EDB723, 23IDA096; 118) REF DYNJ53589D, UDI/DI 10195327046002 (each) 40195327046003 (case), Lot Numbers: 22EBR886; 119) REF DYNJ53589F, UDI/DI 10195327268848 (each) 40195327268849 (case), Lot Numbers: 22LBK584, 22JBI490, 23EBT316, 23DBE864, 23FBV330, 23JBW224, 23JBD077; 120) REF DYNJ53684A, UDI/DI 10193489386875 (each) 40193489386876 (case), Lot Numbers: 22EDB546, 23FDA406; 121) REF DYNJ54834C, UDI/DI 10195327364434 (each) 40195327364435 (case), Lot Numbers: 23CBN409; 122) REF DYNJ56838F, UDI/DI 10195327277857 (each) 40195327277858 (case), Lot Numbers: 23BDA216, 23ADA637, 23CDA919; 123) REF DYNJ56839D, UDI/DI 10195327277864 (each) 40195327277865 (case), Lot Numbers: 22LDA699, 23ADB406; 124) REF DYNJ57539G, UDI/DI 10195327216573 (each) 40195327216574 (case), Lot Numbers: 22ILA375; 125) REF DYNJ57539I, UDI/DI 10195327326319 (each) 40195327326310 (case), Lot Numbers: 23BLA663, 23BLA081, 23CLA931, 23ELA467, 23ELA273; 126) REF DYNJ57539J, UDI/DI 10195327416010 (each) 40195327416011 (case), Lot Numbers: 23FLB065, 23HLA268, 24ALA350, 24BLA089; 127) REF DYNJ57543F, UDI/DI 10195327279028 (each) 40195327279029 (case), Lot Numbers: 23AMF931; 128) REF DYNJ60783B, UDI/DI 10195327361846 (each) 40195327361847 (case), Lot Numbers: 23CBQ596; 129) REF DYNJ60819F, UDI/DI 10195327521264 (each) 40195327521265 (case), Lot Numbers: 23JBJ826, 23KBP266; 130) REF DYNJ60827B, UDI/DI 10195327521356 (each) 40195327521357 (case), Lot Numbers: 23JBT442; 131) REF DYNJ60829D, UDI/DI 10195327521257 (each) 40195327521258 (case), Lot Numbers: 23JBH373; 132) REF DYNJ60898B, UDI/DI 10195327500306 (each) 40195327500307 (case), Lot Numbers: 23IBQ580; 133) REF DYNJ60904B, UDI/DI 10195327500337 (each) 40195327500338 (case), Lot Numbers: 23IBR916, 23JBO985; 134) REF DYNJ61144D, UDI/DI 10195327470562 (each) 40195327470563 (case), Lot Numbers: 23JBI361; 135) REF DYNJ61147F, UDI/DI 10195327470463 (each) 40195327470464 (case), Lot Numbers: 23HBQ275, 23GBS166, 23JBO938; 136) REF DYNJ61169B, UDI/DI 10195327470142 (each) 40195327470143 (case), Lot Numbers: 23HBN068; 137) REF DYNJ61276C, UDI/DI 10195327057534 (each) 40195327057535 (case), Lot Numbers: 22GBA428; 138) REF DYNJ61307B, UDI/DI 10195327072285 (each) 40195327072286 (case), Lot Numbers: 22EMB029, 23FMB397, 23FMH940; 139) REF DYNJ61659A, UDI/DI 10193489929638 (each) 40193489929639 (case), Lot Numbers: 22FBU993, 22JBE926; 140) REF DYNJ61842B, UDI/DI 10195327495541 (each) 40195327495542 (case), Lot Numbers: 23JDB599, 23IDA125; 141) REF DYNJ62097C, UDI/DI 10195327189839 (each) 40195327189830 (case), Lot Numbers: 22KBK806, 22GBN733, 23ABN220, 23BBQ512; 142) REF DYNJ62683A, UDI/DI 10195327213206 (each) 40195327213207 (case), Lot Numbers: 22IBU524; 143) REF DYNJ62683B, UDI/DI 10195327266158 (each) 40195327266159 (case), Lot Numbers: 22LBH032, 22KBM178; 144) REF DYNJ62915C, UDI/DI 10195327497439 (each) 40195327497430 (case), Lot Numbers: 23IDA624, 23KDA999, 23JDC075; 145) REF DYNJ63321B, UDI/DI 10193489958119 (each) 40193489958110 (case), Lot Numbers: 22EBI797, 22EBI800, 22EBC939; 146) REF DYNJ63321C, UDI/DI 10195327273590 (each) 40195327273591 (case), Lot Numbers: 23AMH443 147) REF DYNJ63337C, UDI/DI 10193489943757 (each) 40193489943758 (case), Lot Numbers: 22FBY597; 148) REF DYNJ63337D, UDI/DI 10195327279233 (each) 40195327279234 (case), Lot Numbers: 22LMH286, 23IMF110, 23FMG684; 149) REF DYNJ63341C, UDI/DI 10195327086121 (each) 40195327086122 (case), Lot Numbers: 22EBA823; 150) REF DYNJ63341D, UDI/DI 10195327273620 (each) 40195327273621 (case), Lot Numbers: 23CBK424, 23IBN104; 151) REF DYNJ63342B, UDI/DI 10195327278069 (each) 40195327278060 (case), Lot Numbers: 23IME673; 152) REF DYNJ63342C, UDI/DI 10195327535827 (each) 40195327535828 (case), Lot Numbers: 23JMH264; 153) REF DYNJ63343F, UDI/DI 10195327086138 (each) 40195327086139 (case), Lot Numbers: 22EBP871, 22DBN107; 154) REF DYNJ63345B, UDI/DI 10193489949490 (each) 40193489949491 (case), Lot Numbers: 22DBU955, 22EBL728; 155) REF DYNJ63345C, UDI/DI 10195327270261 (each) 40195327270262 (case), Lot Numbers: 22KBG693, 23JBV870, 23CBA322, 22LBN308, 23EBW583, 23BBC719, 23HBN021; 156) REF DYNJ63346C, UDI/DI 10195327094416 (each) 40195327094417 (case), Lot Numbers: 22EBE095, 22DBK275; 157) REF DYNJ63346D, UDI/DI 10195327270278 (each) 40195327270279 (case), Lot Numbers: 22LMF975, 23GMG961; 158) REF DYNJ64861A, UDI/DI 10195327053635 (each) 40195327053636 (case), Lot Numbers: 22LBN798, 23JBX635; 159) REF DYNJ64862B, UDI/DI 10195327053703 (each) 40195327053704 (case), Lot Numbers: 23GBV226, 23IBO060; 160) REF DYNJ65486A, UDI/DI 10195327303464 (each) 40195327303465 (case), Lot Numbers: 23HMB939; 161) REF DYNJ66725A, UDI/DI 10195327519780 (each) 40195327519781 (case), Lot Numbers: 24ABN082, 24BBF587, 24CBJ383, 24CBB810; 162) REF DYNJ68555A, UDI/DI 10193489994902 (each) 40193489994903 (case), Lot Numbers: 22JBP806, 22IBE010, 23LBB186, 22LBD330, 24ABD085, 24BBE646, 23ABN090, 24CBC563; 163) REF DYNJ68560A, UDI/DI 10193489994810 (each) 40193489994811 (case), Lot Numbers: 22LBL844, 22GBV307, 22FBT470, 22KBL540, 23BBJ004, 22LBM671, 23GBO419, 23EBE953, 23DBP294, 23FBD383; 164) REF DYNJ69489A, UDI/DI 10195327227043 (each) 40195327227044 (case), Lot Numbers: 23IDA325; 165) REF DYNJ69961A, UDI/DI 10195327114381 (each) 40195327114382 (case), Lot Numbers: 22FBP865, 22EBE396, 23FBB740, 24ABS358, 23BBQ633, 23IBN687; 166) REF DYNJ80609A, UDI/DI 10195327127831 (each) 40195327127832 (case), Lot Numbers: 22HBR311; 167) REF DYNJ81581, UDI/DI 10195327122256 (each) 40195327122257 (case), Lot Numbers: 22EBG543; 168) REF DYNJ81581A, UDI/DI 10195327314972 (each) 40195327314973 (case), Lot Numbers: 23CBA210, 23CBA284; 169) REF DYNJ81605, UDI/DI 10195327123888 (each) 40195327123889 (case), Lot Numbers: 22GBG255, 22EBL555, 22LBI697; 170) REF DYNJ81606, UDI/DI 10195327123901 (each) 40195327123902 (case), Lot Numbers: 22FBN598, 22IBT723, 22JBM242; 171) REF DYNJ81610, UDI/DI 10195327123949 (each) 40195327123940 (case), Lot Numbers: 22FBM524, 22JBO418, 22IBP354, 22JBT826; 172) REF DYNJ81610A, UDI/DI 10195327315047 (each) 40195327315048 (case), Lot Numbers: 22LBP958; 173) REF DYNJ81610B, UDI/DI 10195327398316 (each) 40195327398317 (case), Lot Numbers: 23EBA748; 174) REF DYNJ81667, UDI/DI 10195327136444 (each) 40195327136445 (case), Lot Numbers: 22FDB851, 24ADA805; 175) REF DYNJ82163, UDI/DI 10195327182595 (each) 40195327182596 (case), Lot Numbers: 23HMG047; 176) REF DYNJ82166, UDI/DI 10195327182564 (each) 40195327182565 (case), Lot Numbers: 22LDB957, 22LDB316, 22IDB349, 22IDA145, 23CDC564, 23ADB914, 23DDB314, 23ADB903; 177) REF DYNJ82174, UDI/DI 10195327182557 (each) 40195327182558 (case), Lot Numbers: 23DDA941; 178) REF DYNJ82217, UDI/DI 10195327183585 (each) 40195327183586 (case), Lot Numbers: 22LDB170, 23DDB931; 179) REF DYNJ82223, UDI/DI 10195327183547 (each) 40195327183548 (case), Lot Numbers: 23EDB705, 23IMC533, 23IDA296; 180) REF DYNJ82338, UDI/DI 10195327184841 (each) 40195327184842 (case), Lot Numbers: 23IME918, 23HDA944; 181) REF DYNJ82681, UDI/DI 10195327202835 (each) 40195327202836 (case), Lot Numbers: 23IMA511; 182) REF DYNJ82684, UDI/DI 10195327202866 (each) 40195327202867 (case), Lot Numbers: 23JMH608; 183) REF DYNJ84102, UDI/DI 10195327332310 (each) 40195327332311 (case), Lot Numbers: 23FBI526; 184) REF DYNJ900025L, UDI/DI 10195327380946 (each) 40195327380947 (case), Lot Numbers: 23GBO014, 23GBN068, 23JBX038, 23JBT358, 23IBK708, 23LBB804, 23KBT114; 185) REF DYNJ900293J, UDI/DI 10193489915143 (each) 40193489915144 (case), Lot Numbers: 23ABU469, 23ABH968, 22FBM776, 23GBG632, 23DBN440, 22LBF868, 22JBD286, 23IBV188; 186) REF DYNJ900418M, UDI/DI 10195327039042 (each) 40195327039043 (case), Lot Numbers: 22HBD333, 22GBT385, 23ABK050, 23EBG166, 22KBV626, 23CBE942, 23BBE296, 23GBO981, 23KBF640, 23JBL967, 24ABG808, 24ABR765, 24CBM201, 24BBC927; 187) REF DYNJ900532O, UDI/DI 10195327397661 (each) 40195327397662 (case), Lot Numbers: 23FBN480, 23HBS858, 23JBV543, 23JBV628; 188) REF DYNJ900532P, UDI/DI 10195327556709 (each) 40195327556700 (case), Lot Numbers: 24ABI487, 23LBJ156; 189) REF DYNJ900714C, UDI/DI 10193489951363 (each) 40193489951364 (case), Lot Numbers: 22LBM794, 22LBL268, 22GBN822, 22EBM607, 23ABK597, 23DBI028, 23CBW318; 190) REF DYNJ901066I, UDI/DI 10193489944426 (each) 40193489944427 (case), Lot Numbers: 22FBU216; 191) REF DYNJ901066K, UDI/DI 10195327239282 (each) 40195327239283 (case), Lot Numbers: 23HBB464, 23ABQ863, 23ABK586, 22LBL845, 22LBL118, 23EBG260, 23ABK728; 192) REF DYNJ901068F, UDI/DI 10193489944617 (each) 40193489944618 (case), Lot Numbers: 22EBP715; 193) REF DYNJ901068I, UDI/DI 10195327232511 (each) 40195327232512 (case), Lot Numbers: 23ABT178, 23ABT179, 23CBG342, 23ABU397; 194) REF DYNJ901745L, UDI/DI 10195327495749 (each) 40195327495740 (case), Lot Numbers: 24ADA379; 195) REF DYNJ901747M, UDI/DI 10195327495732 (each) 40195327495733 (case), Lot Numbers: 23IDB841, 23LDB111; 196) REF DYNJ902472M, UDI/DI 10195327600785 (each) 40195327600786 (case), Lot Numbers: 24ABV850, 24CBO115, 24CBB693, 24EBD240; 197) REF DYNJ902772F, UDI/DI 10195327461966 (each) 40195327461967 (case), Lot Numbers: 23KBX240, 23KBF407, 23KBB062, 24GBX535, 24ABW915, 24EBG971; 198) REF DYNJ902778G, UDI/DI 10195327462079 (each) 40195327462070 (case), Lot Numbers: 23JBR706, 23JBE626, 24CBI435, 24CBS645; 199) REF DYNJ902817L, UDI/DI 10195327560317 (each) 40195327560318 (case), Lot Numbers: 24BBV212, 24BBK036, 24ABS068, 24DBF200; 200) REF DYNJ903042P, UDI/DI 10195327438388 (each) 40195327438389 (case), Lot Numbers: 23GBD579; 201) REF DYNJ903617G, UDI/DI 10195327368227 (each) 40195327368228 (case), Lot Numbers: 23IBC959, 23HBH140, 23DBT188, 24BBE869, 24ABS862; 202) REF DYNJ903618D, UDI/DI 10195327368395 (each) 40195327368396 (case), Lot Numbers: 24ABR217, 23HBQ723, 24BBQ367, 24BBQ440; 203) REF DYNJ904484F, UDI/DI 10195327165987 (each) 40195327165988 (case), Lot Numbers: 22FBO366; 204) REF DYNJ904500D, UDI/DI 10195327186258 (each) 40195327186259 (case), Lot Numbers: 22HBL697, 22KBH576; 205) REF DYNJ904501I, UDI/DI 10195327166991 (each) 40195327166992 (case), Lot Numbers: 22GBG218, 22FBH402; 206) REF DYNJ904501J, UDI/DI 10195327191283 (each) 40195327191284 (case), Lot Numbers: 22HBI256, 22HBG015; 207) REF DYNJ904645I, UDI/DI 10195327068721 (each) 40195327068722 (case), Lot Numbers: 22FBX104; 208) REF DYNJ904819K, UDI/DI 10195327542931 (each) 40195327542932 (case), Lot Numbers: 24CBM215, 23KBS285; 209) REF DYNJ904862K, UDI/DI 10195327262501 (each) 40195327262502 (case), Lot Numbers: 23AME454, 22JMH815, 23JME977, 23IME830, 23HME446, 23FME593, 23CMC132, 23KMI559, 23KMH537, 23LME743; 210) REF DYNJ905079F, UDI/DI 10195327209001 (each) 40195327209002 (case), Lot Numbers: 23ABH508, 22IBS192, 23ABM734, 22HBH220; 211) REF DYNJ905140C, UDI/DI 10195327286507 (each) 40195327286508 (case), Lot Numbers: 23DDB907; 212) REF DYNJ905220D, UDI/DI 10195327234935 (each) 40195327234936 (case), Lot Numbers: 23BDB248; 213) REF DYNJ905220F, UDI/DI 10195327367855 (each) 40195327367856 (case), Lot Numbers: 23KDA403, 23JDB838; 214) REF DYNJ905437C, UDI/DI 10195327066321 (each) 40195327066322 (case), Lot Numbers: 23ABC672; 215) REF DYNJ905497B, UDI/DI 10193489951639 (each) 40193489951630 (case), Lot Numbers: 22LBP578, 22LBB239, 22IBS021, 22GBG913, 23BBL690, 23BBL698, 22KBK602, 23DBN260, 23DBG744, 23EBQ514; 216) REF DYNJ906182G, UDI/DI 10195327087838 (each) 40195327087839 (case), Lot Numbers: 22LDA731, 22KDB334, 22FDB952; 217) REF DYNJ906182I, UDI/DI 10195327290009 (each) 40195327290000 (case), Lot Numbers: 23CDC239, 23BDA892, 22LDB745; 218) REF DYNJ906182J, UDI/DI 10195327434243 (each) 40195327434244 (case), Lot Numbers: 23GDA608, 23HDC024, 24ADA035, 24DDB119, 24BDA202, 24FDB741; 219) REF DYNJ906303F, UDI/DI 10195327370961 (each) 40195327370962 (case), Lot Numbers: 23KBC207; 220) REF DYNJ906467D, UDI/DI 10195327202620 (each) 40195327202621 (case), Lot Numbers: 23DDC020, 23DDB394, 23IDC207, 23KDA005, 24CDA623; 221) REF DYNJ906473D, UDI/DI 10195327202637 (each) 40195327202638 (case), Lot Numbers: 23JDC099; 222) REF DYNJ906480G, UDI/DI 10195327206666 (each) 40195327206667 (case), Lot Numbers: 23CDB393; 223) REF DYNJ906550B, UDI/DI 10195327221881 (each) 40195327221882 (case), Lot Numbers: 22KDB450, 23CDC091, 23BDB454, 23ADB514, 23JDB645, 24ADA392, 23LDB346, 24ADB200, 24DDA084, 24BDA186; 224) REF DYNJ906715D, UDI/DI 10193489871975 (each) 40193489871976 (case), Lot Numbers: 23ADA170, 22KDB521, 23LDB112, 23KDB513, 23GDA279, 23LDB775; 225) REF DYNJ906715F, UDI/DI 10195327594145 (each) 40195327594146 (case), Lot Numbers: 24ADB674; 226) REF DYNJ906945B, UDI/DI 10195327380960 (each) 40195327380961 (case), Lot Numbers: 23EBF281, 23JBH908, 23KBV585, 23KBR526; 227) REF DYNJ906945C, UDI/DI 10195327568962 (each) 40195327568963 (case), Lot Numbers: 24CBH414, 24DBU254, 24DBD806; 228) REF DYNJ906951B, UDI/DI 10195327381028 (each) 40195327381029 (case), Lot Numbers: 23GBE302, 23IBS109, 23HBN619, 23EBR254, 23HBF708; 229) REF DYNJ906952B, UDI/DI 10195327381035 (each) 40195327381036 (case), Lot Numbers: 23IBT129, 23HBB433; 230) REF DYNJ907105D, UDI/DI 10195327233624 (each) 40195327233625 (case), Lot Numbers: 22JBR447, 22JBR448, 23ABI366, 23FBI805, 23EBG144, 23CBM675, 23FBQ992, 23EBT013; 231) REF DYNJ907400C, UDI/DI 10195327462246 (each) 40195327462247 (case), Lot Numbers: 23IBB465; 232) REF DYNJ907400D, UDI/DI 10195327538552 (each) 40195327538553 (case), Lot Numbers: 24BBA160, 24BBL947, 24BBJ094; 233) REF DYNJ907515I, UDI/DI 10195327345525 (each) 40195327345526 (case), Lot Numbers: 23CBE842, 23GBE214, 23GBJ204, 23HBV237; 234) REF DYNJ907518G, UDI/DI 10195327345495 (each) 40195327345496 (case), Lot Numbers: 23JBK585, 23JBU123, 23FBQ304, 23FBQ987; 235) REF DYNJ907857A, UDI/DI 10195327133160 (each) 40195327133161 (case), Lot Numbers: 22HBK592, 22KBM436; 236) REF DYNJ907857B, UDI/DI 10195327256869 (each) 40195327256860 (case), Lot Numbers: 23JBT943, 23IBE277; 237) REF DYNJ907858A, UDI/DI 10195327131357 (each) 40195327131358 (case), Lot Numbers: 23ABE913, 23FBO603, 23JBS911, 23IBN205; 238) REF DYNJ907860A, UDI/DI 10195327131364 (each) 40195327131365 (case), Lot Numbers: 23FBR681, 23LBF861, 23KBG228; 239) REF DYNJ907904A, UDI/DI 10193489992434 (each) 40193489992435 (case), Lot Numbers: 23AMB902, 23HME883, 23IMC604, 23JME513; 240) REF DYNJ908308, UDI/DI 10195327036386 (each) 40195327036387 (case), Lot Numbers: 23DBK500, 23ABU313, 23ABL428, 23HBS188, 23JBP954, 23GBF293; 241) REF DYNJ908582A, UDI/DI 10195327470272 (each) 40195327470273 (case), Lot Numbers: 23JBA820, 23JBB023; 242) REF DYNJ908820, UDI/DI 10195327185671 (each) 40195327185672 (case), Lot Numbers: 22KDA413, 23IDA450, 23FDB639, 23DDB037, 23EDA360; 243) REF DYNJ908838, UDI/DI 10195327185695 (each) 40195327185696 (case), Lot Numbers: 23CDB147, 23DDB985, 23EDC284, 23GDA478; 244) REF DYNJT1656J, UDI/DI 10195327491642 (each) 40195327491643 (case), Lot Numbers: 23IBQ258, 23JBC665
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.
• Quantity in Commerce: 30092 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.