Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081
1) DYNDTB0529, UDI-DI: 10197344105663(each), 20197344105660(case), Lot Number: All Lot Numbers; 2) DYNDTB1029, UDI-DI: 10197344076956(each), 20197344076953(case), Lot Number: All Lot Numbers; 3) DYNDTB1516, UDI-DI: 10197344105687(each), 20197344105684(case), Lot Number: All Lot Numbers; 4) DYNDTB1530, UDI-DI: 10197344105694(each), 20197344105691(case), Lot Number: All Lot Numbers; 5) DYNDTB1539, UDI-DI: 10197344008254(each), 20197344008251(case), Lot Number: All Lot Numbers; 6) DYNDTB1545, UDI-DI: 10197344098644(each), 20197344098641(case), Lot Number: All Lot Numbers; 7) DYNDTB2045, UDI-DI: 10197344077007(each), 20197344077004(case), Lot Number: All Lot Numbers; 8) DYNDTB0512, UDI-DI: 10197344105656(each), 20197344105653(case), Lot Number: All Lot Numbers; 9) DYNDTB0555, UDI-DI: 10197344105670(each), 20197344105677(case), Lot Number: All Lot Numbers; 10) DYNDTB1022, UDI-DI: 10197344076949(each), 20197344076946(case), Lot Number: All Lot Numbers; 11) DYNDTB1512, UDI-DI: 10197344098613(each), 20197344098610(case), Lot Number: All Lot Numbers; 12) DYNDTB1529, UDI-DI: 10197344098620(each), 20197344098627(case), Lot Number: All Lot Numbers; 13) DYNDTB1537, UDI-DI: 10197344008247(each), 20197344008244(case), Lot Number: All Lot Numbers; 14) DYNDTB1540, UDI-DI: 10197344098637(each), 20197344098634(case), Lot Number: All Lot Numbers; 15) DYNDTB2029, UDI-DI: 10197344076994(each), 20197344076991(case), Lot Number: All Lot Numbers; 16) DYNDTB5077, UDI-DI: 10197344098651(each), 20197344098658(case), Lot Number: All Lot Numbers; 17) DYNDTB1045, UDI-DI: 10197344076963(each), 20197344076960(case), Lot Number: All Lot Numbers; 18) DYNDTB1545D, UDI-DI: 10197344105700(each), 20197344105707(case), Lot Number: All Lot Numbers; 19) DYNDTB2524, UDI-DI: 10197344105717(each), 20197344105714(case), Lot Number: All Lot Numbers; 20) DYNDTB1012, UDI-DI: 10197344076932(each), 20197344076939(case), Lot Number: All Lot Numbers; 21) DYNDTB2012, UDI-DI: 10197344076970(each), 20197344076977(case), Lot Number: All Lot Numbers; 22) DYNDTB2022, UDI-DI: 10197344076987(each), 20197344076984(case), Lot Number: All Lot Numbers; 23) DYNDTB5081, UDI-DI: 10197344098668(each), 20197344098665(case), Lot Number: All Lot Numbers
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →