Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE C

Summary

The FDA issued a Class II for Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK by MEDLINE INDUSTRIES, LP - Northfield. Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits..

Details

Product Description

Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH PACK, Model Number: DYNJ51338C; 6) BRISTOL MYELOGRAM, Model Number: DYNDH1228; 7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A; 8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 9) CATH LAB PACK, Model Number: DYNJ85070; 10) CT SCAN PACK, Model Number: DYNJ39515A; 11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ; 12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D; 13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974; 14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A; 15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020; 16) PORTACATH PACK, Model Number: DYNJ51240A; 17) RADIOLOGY PACK, Model Number: DYNJ43969; 18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I; 19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B

Lot/Code Info: 1) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24IBS428; 2) DYNJ64354A, UDI-DI: 10195327156312(each), 40195327156313(case), Lot Number: 24JBM450; 3) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24JBM593; 4) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24JBN316; 5) DYNJ51338C, UDI-DI: 10193489241716(each), 40193489241717(case), Lot Number: 24JBN784; 6) DYNDH1228, UDI-DI: 10889942572007(each), 40889942572008(case), Lot Number: 24JBU509; 7) DYNJ83961A, UDI-DI: 10195327517748(each), 40195327517749(case), Lot Number: 24JBW818; 8) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24JBX138; 9) DYNJ85070, UDI-DI: 10195327455392(each), 40195327455393(case), Lot Number: 24JBY293; 10) DYNJ39515A, UDI-DI: 10889942753130(each), 40889942753131(case), Lot Number: 24KBA200; 11) 00-398650AJ, UDI-DI: 10195327330903(each), 40195327330904(case), Lot Number: 24KBA758; 12) DYNJ24812D, UDI-DI: 10884389653210(each), 40884389653211(case), Lot Number: 24KBB397; 13) DYNJ69974, UDI-DI: 10195327001117(each), 40195327001118(case), Lot Number: 24KBB454; 14) DYNJ69135A, UDI-DI: 10195327140496(each), 40195327140497(case), Lot Number: 24KBC186; 15) DYNJ45020, UDI-DI: 10888277086685(each), 40888277086686(case), Lot Number: 24KBC962; 16) DYNJ51240A, UDI-DI: 10889942493524(each), 40889942493525(case), Lot Number: 24KBE652; 17) DYNJ43969, UDI-DI: 10888277077089(each), 40888277077080(case), Lot Number: 24KBF965; 18) DYNJ41932I, UDI-DI: 10198459078699(each), 40198459078690(case), Lot Number: 24KBG499; 19) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24KBG961; 20) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24KBH847

Quantity Affected: 4022 units

Reason for Recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-03-03

Company