FDA Medical devices recall · April 23, 2025

Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE… recall

Read the official FDA notice ↗

Product

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1591-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.