Class 2 Device Recall Medline

• Date Initiated by Firm: September 02, 2026
• Date Posted: October 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0171-2027
• Recall Event ID: 99886
• Product Classification: Central venous catheter tray - Product Code OFF
• Product: Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product number/SKU DYNJ68420D; 5) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692J; 6) PRODUCT VASCULAR LAFAYETTE, Medline product number/SKU DYNJ908620D; 7) CHRISTUS SPOHN AV ACCESS PACK, Medline product number/SKU DYNJ60973A; 8) TOL VEIN PACK, Medline product number/SKU DYNJ80861F; 9) THROMBECTOMY PACK-LF, Medline product number/SKU DYNJ0160348B; 10) VEIN PACK, Medline product number/SKU DYNJ67308A; 11) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692I; 12) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692G; 13) BYPASS ACCESSORY, Medline product number/SKU DYNJ52036F; 14) TOL VEIN PACK, Medline product number/SKU DYNJ80861C; 15) MANSFIELD ACCESS GRAFT, Medline product number/SKU DYNJ909985; 16) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732I; 17) CAROTID ENDARTERECTOMY PK, Medline product number/SKU DYNJ85516; 18) RADIAL ARTERY PACK, Medline product number/SKU DYNJ83938; 19) AV FISTULA PACK, Medline product number/SKU DYNJ01966N; 20) FH A V FISTULA PACK-LF, Medline product number/SKU DYNJ51804G; 21) VEIN PACK SHD, Medline product number/SKU DYNJ68420C; 22) VEIN PACK SHD, Medline product number/SKU DYNJ68420B; 23) AV FISTULA, Medline product number/SKU DYNJ906945; 24) VEIN PACK SHD, Medline product number/SKU DYNJ68420A; 25) MHC AV FISTULA, Medline product number/SKU DYNJ903705G.
• Code Information: Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 26BMB707; Medline product number/SKU DYNJ0665837G, UDI/DI 10198459543685 (each) 40198459543686 (case), Lot Number 26BBG404; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 26AMI490; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 26ABM059; Medline product number/SKU DYNJ0665837G, UDI/DI 10198459543685 (each) 40198459543686 (case), Lot Number 26ABC613; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25LDB280; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25LBA755; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25KMJ136; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25KBH758; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25JMK339; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25JDB137; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25JBW131; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25IMF439; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25IBO322; Medline product number/SKU DYNJ60973A, UDI/DI 10198459037948 (each) 40198459037949 (case), Lot Number 25IBE177; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25HME176; Medline product number/SKU DYNJ80861F, UDI/DI 10198459398384 (each) 40198459398385 (case), Lot Number 25HBP381; Medline product number/SKU DYNJ908620D, UDI/DI 10198459434402 (each) 40198459434403 (case), Lot Number 25HBL650; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 25GDB473; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25GDA168; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25GBW279; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25GBE133; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25FMB034; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25FDA914; Medline product number/SKU DYNJ905692J, UDI/DI 10198459298479 (each) 40198459298470 (case), Lot Number 25FDA450; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25FBF590; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25EMF399; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25EBG978; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25CMG772; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 25CBR821; Medline product number/SKU DYNJ905692I, UDI/DI 10198459195167 (each) 40198459195168 (case), Lot Number 25BDB456; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 25BDA784; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 25BBN759; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25BBB945; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 25AMI745; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25AMH019; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 25AMG519; Medline product number/SKU DYNJ905692I, UDI/DI 10198459195167 (each) 40198459195168 (case), Lot Number 25ADA749; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 25ADA594; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25ABQ722; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 25ABQ316; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 25ABB193; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 24LMD985; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24LDA353; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24KDA598; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24KBT683; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24KBN817; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24IBB060; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 24HMK312; Medline product number/SKU DYNJ0826732J, UDI/DI 10198459008764 (each) 40198459008765 (case), Lot Number 24HMJ371; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24HDA022; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24HBS349; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 24GME662; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24GBB730; Medline product number/SKU DYNJ905692G, UDI/DI 10198459024146 (each) 40198459024147 (case), Lot Number 24FDB212; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24FBM287; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24EBR396; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 24DDB695; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24DBP489; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24DBC279; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 24CBD982; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 24BBM799; Medline product number/SKU DYNJ80861C, UDI/DI 10195327506117 (each) 40195327506118 (case), Lot Number 24ABS359; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 24ABE288; Medline product number/SKU DYNJ909985, UDI/DI 10195327531911 (each) 40195327531912 (case), Lot Number 24ABB464; Medline product number/SKU DYNJ0826732I, UDI/DI 10193489377972 (each) 40193489377973 (case), Lot Number 23LME164; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23LMA870; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23LBS811; Medline product number/SKU DYNJ85516, UDI/DI 10195327511593 (each) 40195327511594 (case), Lot Number 23LBR472; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23LBL475; Medline product number/SKU DYNJ85516, UDI/DI 10195327511593 (each) 40195327511594 (case), Lot Number 23LBE170; Medline product number/SKU DYNJ0826732I, UDI/DI 10193489377972 (each) 40193489377973 (case), Lot Number 23KMF466; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 23KDC246; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23KBJ444; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23KBH513; Medline product number/SKU DYNJ85516, UDI/DI 10195327511593 (each) 40195327511594 (case), Lot Number 23JBI659; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23JBG813; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 23JBF754; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23JBC969; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23IBT687; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23IBL104; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23IBJ790; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23HMH042; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 23HDA183; Medline product number/SKU DYNJ83938, UDI/DI 10195327317232 (each) 40195327317233 (case), Lot Number 23HBO900; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23GME764; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23GBR115; Medline product number/SKU DYNJ01966N, UDI/DI 10193489383768 (each) 40193489383769 (case), Lot Number 23FMG009; Medline product number/SKU DYNJ52036F, UDI/DI 10195327405304 (each) 40195327405305 (case), Lot Number 23FBT240; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23FBS476; Medline product number/SKU DYNJ01966N, UDI/DI 10193489383768 (each) 40193489383769 (case), Lot Number 23EMF846; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23EBJ222; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23DDB964; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23DDB513; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23CDC117; Medline product number/SKU DYNJ68420D, UDI/DI 10195327341718 (each) 40195327341719 (case), Lot Number 23CBT125; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 23BDB219; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 23AME485; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22OBM668; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22LBB746; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBW158; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBQ170; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBE339; Medline product number/SKU DYNJ68420C, UDI/DI 10195327206062 (each) 40195327206063 (case), Lot Number 22KBA312; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22JME166; Medline product number/SKU DYNJ01966N, UDI/DI 10193489383768 (each) 40193489383769 (case), Lot Number 22IMA429; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22IDB621; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22IBR892; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22HDB275; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22HBG228; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22GDB613; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22GDA289; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22GBA328; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22FMG964; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22FBE109; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22FBE104; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22FBA284; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22EDB536; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22EDB062; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22EBN485; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22DBO990; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 22CBS193; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 22CBP282; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 22CBJ075; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22BDA696; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 22ADB771; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 22ADB470; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 22ABJ294; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 22ABF980; Medline product number/SKU DYNJ67308A, UDI/DI 10195327015695 (each) 40195327015696 (case), Lot Number 21LBA620; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 21KDA674; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 21KBV460; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 21KBS378; Medline product number/SKU DYNJ68420B, UDI/DI 10195327034313 (each) 40195327034314 (case), Lot Number 21KBI602; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 21KBF475; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21JDB751; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21JBB317; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21IDA765; Medline product number/SKU DYNJ903705G, UDI/DI 10193489345506 (each) 40193489345507 (case), Lot Number 21IBX705; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21HDC282; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21HDA988; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 21HDA843; Medline product number/SKU DYNJ900454C, UDI/DI 10193489857108 (each) 40193489857109 (case), Lot Number 21HBP947; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21HBE372; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21GBL267; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21FDB477; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21FBP175; Medline product number/SKU DYNJ903705G, UDI/DI 10193489345506 (each) 40193489345507 (case), Lot Number 21FBI212; Medline product number/SKU DYNJ68420A, UDI/DI 10193489913767 (each) 40193489913768 (case), Lot Number 21FBE487; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21FBC661; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21DDB231; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21DBK091; Medline product number/SKU DYNJ906945, UDI/DI 10193489299274 (each) 40193489299275 (case), Lot Number 21DBD028; Medline product number/SKU DYNJ0160348B, UDI/DI 10889942211593 (each) 40889942211594 (case), Lot Number 21BDB946; Medline product number/SKU DYNJ51804G, UDI/DI 10193489475449 (each) 40193489475440 (case), Lot Number 21ADB109.
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 9/2/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com, Recall Reference #: R-26-201-FG, Recall Code: 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable." Those consignees who further distributed the product were directed to notify the parties to whom the affected product was distributed. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 8374 kits
• 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.