Medline Industries, LP

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 7) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 8) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 9) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 10) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 11) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 12) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 16) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 17) CHEST TUBE SUPPLIES, Model Number: DYKM2131

1) CVI4500A, UDI-DI: 10653160327646(each), 653160327649(case), Lot Number: 2020121550; 2) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024030690; 3) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024052290; 4) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024060590; 5) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2025012890; 6) DYKM1751A, UDI-DI: 10193489111002(each), 20193489111009(case), Lot Number: 2023121190; 7) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023060290; 8) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023070590; 9) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023111590; 10) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023120590; 11) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024022190; 12) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024080190; 13) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024101490; 14) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023050490; 15) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023071290; 16) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024012490; 17) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024071790; 18) DYKM1767B, UDI-DI: 10193489112368(each), 20193489112365(case), Lot Number: 2023102790; 19) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2024031590; 20) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2025013190; 21) DYKM1781A, UDI-DI: 10653160352730(each), 653160352733(case), Lot Number: 2024092390; 22) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024053190; 23) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024062890; 24) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2025011090; 25) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024041790; 26) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024061890; 27) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024072390; 28) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024093090; 29) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2025010890; 30) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2025020690; 31) DYKM1801B, UDI-DI: 10653160360421(each), 653160360424(case), Lot Number: 2024011790; 32) DYKM1801B, UDI-DI: 10653160360421(each), 653160360424(case), Lot Number: 2024062890; 33) DYKM1801B, UDI-DI: 10653160360421(each), 653160360424(case), Lot Number: 2024100790; 34) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024032990; 35) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024071990; 36) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2023101680; 37) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2024010880; 38) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2023112780; 39) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2024040180; 40) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023072590; 41) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023080190; 42) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023081490; 43) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023121490; 44) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2024012590; 45) DYKM1977B, UDI-DI: 10653160360797(each), 653160360790(case), Lot Number: 2023063090; 46) DYKM1977B, UDI-DI: 10653160360797(each), 653160360790(case), Lot Number: 2023120890; 47) DYKM1977B, UDI-DI: 10653160360797(each), 653160360790(case), Lot Number: 2024091290; 48) DYKM2131, UDI-DI: 10195327058715(each), 40195327058716(case), Lot Number: 23ALA008