medical Class II Updated 2025-01-01

MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand, medical procedure convenience kits, labeled a

Recalled Product

Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; 6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D; 7) NEURO BUNDLE-LF, SKU DYNJ40095A; 8) NEURO BUNDLE-LF, SKU DYNJ40095B; 9) NEURO BUNDLE-LF, SKU DYNJ40095C; 10) NEURO BUNDLE-LF, SKU DYNJ40095D; 11) NEURO PACK-LF, SKU DYNJ42844D; 12) WMC VP SHUNT PACK-LF, SKU DYNJ50629J; 13) NEURO PACK, SKU DYNJ54255A; 14) NEURO CHRISTUS, SKU DYNJ61190A; 15) NEURO KIT, SKU DYNJ62854B; 16) NEURO KIT, SKU DYNJ62854C; 17) NEURO PACK NTX, SKU DYNJ66213D; 18) NEURO PACK, SKU DYNJ67628C; 19) BASIC NEURO CUSTOM, SKU DYNJ83387; 20) BASIC NEURO CUSTOM, SKU DYNJ83387A; 21) HALY NEURO PACK, SKU DYNJ87308; 22) FHWC NEURO, SKU DYNJ906131B; 23) CRANI, SKU DYNJ907865; 24) KIT NEURO LAFAYETTE, SKU DYNJ908615C; 25) GENERAL NEURO, SKU DYNJ909744

Hazard / Issue

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: CDS780119T, 10888277762688 (each), 40888277762689 (case), Lot Numbers: 20EBU829; UDI-DI: CDS981327Q, 10195327080365 (each), 40195327080366 (case), Lot Numbers: 22FMH830 22FMF883; UDI-DI: DYNJ0311501I, 10889942265886 (each), 40889942265887 (case), Lot Numbers: 22DMF117; UDI-DI: DYNJ37741D, 10195327548940 (each), 40195327548941 (case), Lot Numbers: 24EMD032; UDI-DI: DYNJ39836C, 10193489510324 (each), 40193489510325 (case), Lot Numbers: 20JMB588 20GMD367 20EMB420 20CMC383 20CMA256; UDI-DI: DYNJ39836D, 10193489477177 (each), 40193489477178 (case), Lot Numbers: 22EMA431 22CMC948 22BMD597 22AMG597 21JMF846 21IMA074 21GMF465 21GMC844 21CME103 21CMD623 21BMC249; UDI-DI: DYNJ40095A, 10193489370690 (each), 40193489370691 (case), Lot Numbers: 21KME983 21JMB244 21JMB245 21HMA330 21EME688 21DME512 21CMA323 20LMD710 20HMB030; UDI-DI: DYNJ40095B, 10195327068325 (each), 40195327068326 (case), Lot Numbers: 22GMB406 22EMA845 22CME763; UDI-DI: DYNJ40095C, 10195327211028 (each), 40195327211029 (case), Lot Numbers: 22JMH236; UDI-DI: DYNJ40095D, 10195327281250 (each), 40195327281251 (case), Lot Numbers: 24HMC151 24GMA340 24DMK362 24CMH592 24BMF793 24AMF590 24AMD886 23LMB475 23KMD199 23IMF930 23HMG523 23HMB850 23GMI744 23GMH136 23FMD605 23EMC157 23CME914 23BMC902 22LME175; UDI-DI: DYNJ42844D, 10193489880564 (each), 40193489880565 (case), Lot Numbers: 22HBZ336; UDI-DI: DYNJ50629J, 10195327081324 (each), 40195327081325 (case), Lot Numbers: 22FBF021; UDI-DI: DYNJ54255A, 10889942765256 (each), 40889942765257 (case), Lot Numbers: 20LBO578 20HBM398 20FBW118 20EBG032 20DBF296; UDI-DI: DYNJ61190A, 10193489453355 (each), 40193489453356 (case), Lot Numbers: 23HBX568 23GBU378 23EBU255 23EBB228 23CBK006 23BBF587 22LBP590 22LBO797 22KBH699 22JBI769 22IBF404 22HMF895 22EMH841 22DMI740 22CMH488 22CME013 21JME676 21IMG224 21IMB620 21GMC966 21EMB917 21BMD698 21BMD492 21BMB573; UDI-DI: DYNJ62854B, 10193489324402 (each), 40193489324403 (case), Lot Numbers: 20HBA904; UDI-DI: DYNJ62854C, 10193489426984 (each), 40193489426985 (case), Lot Numbers: 24ABR077 23LBT405 23KBM929 23GBJ934 23FBA134 23DBP199 23BBI534 22LBQ392 22IBU624 22DBO531 22DBE837 21LBF713 21LBF714 21KBW798 21KBU432 21IBO584 21EBS026 21EBS045 21ABD769 21ABF202 20JBF504; UDI-DI: DYNJ66213D, 10195327345129 (each), 40195327345120 (case), Lot Numbers: 23IBN119 23HBT681 23GBA060 23FBF235 23DBR382 23CBI721; UDI-DI: DYNJ67628C, 10195327690342 (each), 40195327690343 (case), Lot Numbers: 24HMA885; UDI-DI: DYNJ83387, 10195327262945 (each), 40195327262946 (case), Lot Numbers: 22LBP363; UDI-DI: DYNJ83387A, 10195327365684 (each), 40195327365685 (case), Lot Numbers: 23IBS038 23GBF619 23EBP127 23DBI802; UDI-DI: DYNJ87308, 10198459025631 (each), 40198459025632 (case), Lot Numbers: 24GMB920; UDI-DI: DYNJ906131B, 10193489932386 (each), 40193489932387 (case), Lot Numbers: 22FBP752 22EBI045 22EBH247; UDI-DI: DYNJ907865, 10193489908725 (each), 40193489908726 (case), Lot Numbers: 22CMB545 22BMA169 21HMB808; UDI-DI: DYNJ908615C, 10198459082702 (each), 40198459082703 (case), Lot Numbers: 24HBS615; UDI-DI: DYNJ909744, 10195327465636 (each), 40195327465637 (case), Lot Numbers: 24ALA727 23JLA320
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