MEDLINE procedure kits labeled as follows: 1) COMBINED recall
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3)…
Why was MEDLINE procedure kits labeled as follows: 1) COMBINED recalled?
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3)…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Distribution
- US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
- Recall date
- December 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)