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
This recall is currently active, issued April 17, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 3, 2025
- Posted
- April 17, 2025
- Recall Number
- Z-1591-2025
- Quantity
- 4022 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
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
Root Cause
Under Investigation by firm
Action Taken
An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 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 response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.