MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND

Summary

The FDA issued a Class II for MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, R by MEDLINE INDUSTRIES, LP - Northfield. Reason: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position..

Details

Product Description

MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869; 6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035; 7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040; 8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O; 9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C; 10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B; 11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C; 12) CONTINUOUS EPIDURAL, REF PAIN1271A; 13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B; 14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317; 15) 20G CONT. EPID TRAY, REF PAIN1353B; 16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358; 17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361; 18) JHAC CONT EPIDURAL, REF PAIN1437A; 19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B; 20) EPIDURAL CATH KIT, REF PAIN1536A; 21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547; 22) EPIDURAL TRAY, REF PAIN1558; 23) CONTINUOUS EPIDURAL, REF PAIN1581A; 24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A; 25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B; 26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A; 27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636; 28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A; 29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A; 30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709; 31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A; 32) CONTINUOUS EPIDURAL, REF PAIN1766A; 33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806; 34) EPIDURAL TRAY IMF 103130, REF PAIN1807; 35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816; 36) CONTINUOUS EPIDURAL, REF PAIN1844; 37) CSE TRAY, REF PAIN1845; 38) BWH L&D EPIDURAL KIT, REF PAIN1846; 39) 17G CONT. EPI - MRI SAFE, REF PAIN1854; 40) 17G L&D CONT. EPIDURAL, REF PAIN1855; 41) CONTINUOUS/CSE TRAY, REF PAIN1856; 42) CONTINUOUS/CSE TRAY, REF PAIN1856A; 43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864; 44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A; 45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878; 46) CSE TRAY, REF PAIN1885; 47) TEAM HEALTH EPIDURAL, REF PAIN1887; 48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888; 49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890; 50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892; 51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893; 52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894; 53) CSE TRAY, REF PAIN1898; 54) CSE TRAY, REF PAIN1904; 55) 17/25G CSE TRAY, REF PAIN1919; 56) CSE TRAY, REF PAIN1920; 57) 17/25G CSE TRAY, REF PAIN1937; 58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940; 59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958; 60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967; 61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014; 62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025; 63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026; 64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028; 65) 17G CONT EPIDURAL NYLON, REF PAIN9030; 66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031; 67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034; 68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035; 69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036; 70) REINIF 19G EPI CATH S STERILE, REF REPICATH19; 71) CONT. EPIDURAL TRAY, REF SAMPA0105; 72) EPIDURAL CATH PACK, REF SAMPA0106; 73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110; 74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111

Lot/Code Info: Codes: 1) DYNJRA1268B, UDI/DI 10193489370485 (each) 40193489370486 (case), Lot Numbers: 20FLA512, 20HLA422, 20ILA296, 20ILA327, 20LLA223, 21ALA087, 21CLA525; 2) DYNJRA1268C, UDI/DI 10193489905830 (each) 40193489905831 (case), Lot Numbers: 21ELA224, 21ELA333, 21GLA292, 21GLA895, 21HLA924, 21ILA773, 21JLA824, 22ALA237, 22BLA899, 22DLA197, 22DLA409, 22ELA583, 22ELB120, 22FLA820, 22FLB163, 22GLB081, 22HLA566, 22ILA092, 22LLA800, 23DLA368, 23FLA942, 23GLA321, 23HLA910, 23ILA593, 23JLA268; 3) DYNJRA1739A, UDI/DI 1019348992495 (each) 40193489924955 (case), Lot Numbers: 23CBE392; 4) DYNJRA1739B, UDI/DI 10195327411237 (each) 40195327411238 (case), Lot Numbers: 23FBL394, 23GBV201, 23HBG282, 23HBG968, 23IBQ191; 5) DYNJRA1869, UDI/DI 10195327018818 (each) 40195327018819 (case), Lot Numbers: 23CBE391; 6) DYNJRA9035, UDI/DI 10884389618448 (each) 40884389618449 (case), Lot Numbers: 22GBO435, 22IBI073, 23BBB167, 23BBS677, 23CBL304, 23FBI382; 7) DYNJRA9040, UDI/DI 10193489830514 (each) 40193489830515 (case), Lot Numbers: 23CBO446, 23DBK742, 23HBG091, 23HBG092; 8) EPIREINF19O, UDI/DI 10195327222970 (each) 40195327222971 (case), Lot Numbers: 22HBB281, 23EBO266, 23GBA230, 23HBN806, 23HBR131, 23HBY420; 9) EPIREINF29C, UDI/DI 10195327114367 (each) 40195327114368 (case), Lot Numbers: 22FBU886, 22HBD608, 22KBK655, 22NBE738, 23ABH589, 23DBK772, 23DBN448, 23JBU253; 10) PAIN0384B, UDI/DI 10193489926842 (each) 40193489926843 (case), Lot Numbers: 23BMC466, 23FMJ516, 23FMJ523, 23FMJ721, 23HMA617, 23LMB080, 23LMC430; 11) PAIN1069C, UDI/DI 1019532736489 (each) 40195327364893 (case), Lot Numbers: 23ELA637, 23GLA586, 23HLA616, 23JLB208; 12) PAIN1271A, UDI/DI 10193489619201 (each) 40193489619202 (case), Lot Numbers: 23BLA979; 13) PAIN1281B, UDI/DI 10195327288211 (each) 40195327288212 (case), Lot Numbers: 22KLA735, 23ALA157; 14) PAIN1317, UDI/DI 10888277797109 (each) 40888277797100 (case), Lot Numbers: 22GLA179, 22HLB332, 23CLA460, 23DLA279, 23ELB138, 23FLA944, 23GLA948, 23HLB106, 23ILA924, 23JLB213, 23KLB167; 15) PAIN1353B, UDI/DI 10193489336726 (each) 40193489336727 (case), Lot Numbers: 20ELA452; 16) PAIN1358, UDI/DI 10193489586749 (each) 40193489586740 (case), Lot Numbers: 22FLB088, 23CLA573; 17) PAIN1361, UDI/DI 10193489586848 (each) 40193489586849 (case), Lot Numbers: 22FLA642, 22GLA243, 23ILA612, 23JLA051; 18) PAIN1437A, UDI/DI 1019532713519 (each) 40195327135196 (case), Lot Numbers: 22EBA985, 23ABO995, 23KBH798, 23KBR650; 19) PAIN1453B, UDI/DI 1019532731038 (each) 40195327310388 (case), Lot Numbers: 22LLB007, 23ALA593, 23BLA987; 20) PAIN1536A, UDI/DI 10193489288582 (each) 40193489288583 (case), Lot Numbers: 23CLA081; 21) PAIN1547, UDI/DI 10193489813081 (each) 40193489813082 (case), Lot Numbers: 23BLB100, 23FLA069, 23JLA884; 22) PAIN1558, UDI/DI 10193489213584 (each) 40193489213585 (case), Lot Numbers: 23BMH883, 23GMA342, 23GMC058, 23IMC928; 23) PAIN1581A, UDI/DI 10195327351809 (each) 40195327351800 (case), Lot Numbers: 23BLB024, 23CLA024, 23ELB140; 24) PAIN1587A, UDI/DI 10193489336368 (each) 40193489336369 (case), Lot Numbers: 23BLA078, 23FLA277; 25) PAIN1587B, UDI/DI 10195327539511 (each) 40195327539512 (case), Lot Numbers: 23JLB184; 26) PAIN1605A, UDI/DI 1019348946814 (each) 40193489468145 (case), Lot Numbers: 22KLA748, 23BLA153; 27) PAIN1636, UDI/DI 10193489312720 (each) 40193489312721 (case), Lot Numbers: 22FLA297; 28) PAIN1644A, UDI/DI 10195327427863 (each) 40195327427864 (case), Lot Numbers: 23GLA589, 23HLA915, 23JLA225, 23KLA831; 29) PAIN1667A, UDI/DI 10193489472868 (each) 40193489472869 (case), Lot Numbers: 22FLB089, 23CLA442, 23ELA958, 23FLA945, 23HLA916, 23KLB169; 30) PAIN1709, UDI/DI 10193489816044 (each) 40193489816045 (case), Lot Numbers: 23CLA719; 31) PAIN1709A, UDI/DI 10195327411220 (each) 40195327411221 (case), Lot Numbers: 23ELA723, 23ILA927; 32) PAIN1766A, UDI/DI 10195327361488 (each) 40195327361489 (case), Lot Numbers: 23FLB123, 23GLA313; 33) PAIN1806, UDI/DI 10195327134563 (each) 40195327134564 (case), Lot Numbers: 22ELA290, 22FLB111; 34) PAIN1807, UDI/DI 1019532713502 (each) 40195327135028 (case), Lot Numbers: 22FLB112, 23DLA445; 35) PAIN1816, UDI/DI 10195327145453 (each) 40195327145454 (case), Lot Numbers: 22GLA509, 22GLA531; 36) PAIN1844, UDI/DI 10195327207748 (each) 40195327207749 (case), Lot Numbers: 23BLA981, 23ELB126, 23ILA404, 23ILB016; 37) PAIN1845, UDI/DI 10195327210823 (each) 40195327210824 (case), Lot Numbers: 23ELA640; 38) PAIN1846, UDI/DI 10195327211639 (each) 40195327211630 (case), Lot Numbers: 23DLA446; 39) PAIN1854, UDI/DI 10195327225858 (each) 40195327225859 (case), Lot Numbers: 22JLB193, 22LLA402; 40) PAIN1855, UDI/DI 10195327226015 (each) 40195327226016 (case), Lot Numbers: 22LLA455, 23CLA867; 41) PAIN1856, UDI/DI 10195327228996 (each) 40195327228997 (case), Lot Numbers: 22JLB162, 22LLA409; 42) PAIN1856A, UDI/DI 10195327338015 (each) 40195327338016 (case), Lot Numbers: 23HLB303; 43) PAIN1864, UDI/DI 10195327238766 (each) 40195327238767 (case), Lot Numbers: 22HLB077, 22LLA731, 23FLA012; 44) PAIN1864A, UDI/DI 10195327517090 (each) 40195327517091 (case), Lot Numbers: 23LLA277; 45) PAIN1878, UDI/DI 10195327257842 (each) 40195327257843 (case), Lot Numbers: 23ALA348, 23ELA724; 46) PAIN1885, UDI/DI 10195327269159 (each) 40195327269150 (case), Lot Numbers: 22LLA664, 23DLA281, 23ELA641; 47) PAIN1887, UDI/DI 10195327272852 (each) 40195327272853 (case), Lot Numbers: 22KLA920; 48) PAIN1888, UDI/DI 10195327272913 (each) 40195327272914 (case), Lot Numbers: 23BLA151, 23BLB105; 49) PAIN1890, UDI/DI 10195327282387 (each) 40195327282388 (case), Lot Numbers: 23BLB106; 50) PAIN1892, UDI/DI 10195327283049 (each) 40195327283040 (case), Lot Numbers: 23BLB026, 23ELB077, 23ILA928; 51) PAIN1893, UDI/DI 10195327283865 (each) 40195327283866 (case), Lot Numbers: 23BLA283, 23GLA624, 23HLA803; 52) PAIN1894, UDI/DI 10195327283896 (each) 40195327283897 (case), Lot Numbers: 23BLB107, 23ELA725, 23GLA370; 53) PAIN1898, UDI/DI 10195327297596 (each) 40195327297597 (case), Lot Numbers: 23BLA284, 23BLA726; 54) PAIN1904, UDI/DI 10195327312336 (each) 40195327312337 (case), Lot Numbers: 23ELB079, 23GLA947, 23HLA774; 55) PAIN1919, UDI/DI 10195327342807 (each) 40195327342808 (case), Lot Numbers: 23CLA461, 23GLB137, 23HLA653, 23ILA462; 56) PAIN1920, UDI/DI 10195327346072 (each) 40195327346073 (case), Lot Numbers: 23FLA827, 23HLA259; 57) PAIN1937, UDI/DI 10195327362737 (each) 40195327362738 (case), Lot Numbers: 23ELB122; 58) PAIN1940, UDI/DI 10195327365332 (each) 40195327365333 (case), Lot Numbers: 23ELB080; 59) PAIN1958, UDI/DI 10195327399986 (each) 40195327399987 (case), Lot Numbers: 23GBV335, 23IBL615; 60) PAIN1967, UDI/DI 10195327417482 (each) 40195327417483 (case), Lot Numbers: 23IDA109, 23KDB373; 61) PAIN2014, UDI/DI 10195327510763 (each) 40195327510764 (case), Lot Numbers: 23JBS142; 62) PAIN9025, UDI/DI 10193489777697 (each) 40193489777698 (case), Lot Numbers: 22FLB008, 22LLA741; 63) PAIN9026, UDI/DI 10193489777703 (each) 40193489777704 (case), Lot Numbers: 23ALA479, 23ALA534, 23ALA753, 23BLA647, 23BLB091, 23CLA295; 64) PAIN9028, UDI/DI 10193489295689 (each) 40193489295680 (case), Lot Numbers: 22GLA287, 22ILA124, 23CLA410; 65) PAIN9030, UDI/DI 10193489295641 (each) 40193489295642 (case), Lot Numbers: 22FLB009, 22HLB347, 22ILA078, 23CLA407; 66) PAIN9031, UDI/DI 10195327146429 (each) 40195327146420 (case), Lot Numbers: 22GLA057, 23ALA831, 23ELA887, 23GLA871; 67) PAIN9034, UDI/DI 10195327287757 (each) 40195327287758 (case), Lot Numbers: 23ABB439, 23ABG209, 23BBS341, 23CBO460, 23EBM262, 23EBR039, 23FBI376, 23FBI377; 68) PAIN9035, UDI/DI 10195327288006 (each) 40195327288007 (case), Lot Numbers: 23BBP889; 69) PAIN9036, UDI/DI 10195327288013 (each) 40195327288014 (case), Lot Numbers: 23BBN205, 23GBW665, 23HBQ304, 23HBU314, 23JBO472; 70) REPICATH19, UDI/DI 10193489630848 (each) 40193489630849 (case), Lot Numbers: 22ABM967, 22GBG329, 22HBO372, 23CBI450, 23GBI168, 23GBI169, 23GBI170, 23HBI971; 71) SAMPA0105, UDI/DI 10195327026240 (each) 40195327026241 (case), Lot Numbers: 21JLA580; 72) SAMPA0106, UDI/DI 10195327028169 (each) 40195327028160 (case), Lot Numbers: 21LBY057; 73) SAMPA0110, UDI/DI 10195327097004 (each) 40195327097005 (case), Lot Numbers: 22BLA107, 22CLA719, 22CLA850; 74) SAMPA0111, UDI/DI 10195327204693 (each) 40195327204694 (case), Lot Numbers: 22LLA665

Reason for Recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-10-16

Company