MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V

Recall number

Z-1592-2025

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V

Status

Open, Classified

Initiated

2025-03-03

Posted

2025-04-17

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

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.

Quantity

3205 units

Distribution

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

Lot, serial or model codes

1) DYNJ59310D, UDI-DI: 10195327402396(each), 40195327402397(case), Lot Number: 24IBB643; 2) DYNJ32436A, UDI-DI: 10884389686614(each), 40884389686615(case), Lot Number: 24IBG295; 3) DYNJ35586G, UDI-DI: 10193489663235(each), 40193489663236(case), Lot Number: 24IBG343; 4) DYNJ55343B, UDI-DI: 10195327478056(each), 40195327478057(case), Lot Number: 24IBG535; 5) DYNJ55343B, UDI-DI: 10195327478056(each), 40195327478057(case), Lot Number: 24IBH248; 6) DYNJ65027B, UDI-DI: 10193489471991(each), 40193489471992(case), Lot Number: 24IBH653; 7) DYNJ48196C, UDI-DI: 10193489712469(each), 40193489712460(case), Lot Number: 24IBL194; 8) DYNJ40480, UDI-DI: 10884389861196(each), 40884389861197(case), Lot Number: 24IBO308; 9) DYNJ900523B, UDI-DI: 10195327628703(each), 40195327628704(case), Lot Number: 24IBT180; 10) DYNJ19758I, UDI-DI: 10193489992328(each), 40193489992329(case), Lot Number: 24IBV182; 11) SYNJ10280C, UDI-DI: 10195327373597(each), 40195327373598(case), Lot Number: 24JBL521; 12) DYNJ48196C, UDI-DI: 10193489712469(each), 40193489712460(case), Lot Number: 24JBM305; 13) DYNJ27949F, UDI-DI: 10195327016104(each), 40195327016105(case), Lot Number: 24JBM849; 14) DYNJ41874C, UDI-DI: 10195327428914(each), 40195327428915(case), Lot Number: 24JBM893; 15) DYNJ83208A, UDI-DI: 10198459097065(each), 40198459097066(case), Lot Number: 24JBM959; 16) DYNJ56729, UDI-DI: 10889942676026(each), 40889942676027(case), Lot Number: 24JBT045; 17) DYNJCD0326, UDI-DI: 10193489203509(each), 40193489203500(case), Lot Number: 24JBU078; 18) DYNJ80084, UDI-DI: 10195327012014(each), 40195327012015(case), Lot Number: 24JBU113; 19) DYNJ39111A, UDI-DI: 10195327429744(each), 40195327429745(case), Lot Number: 24JBU159; 20) DYNJ25102I, UDI-DI: 10195327573812(each), 40195327573813(case), Lot Number: 24JBU436; 21) DYNJ62339, UDI-DI: 10193489646924(each), 40193489646925(case), Lot Number: 24JBV115; 22) DYNJ43278C, UDI-DI: 10193489957358(each), 40193489957359(case), Lot Number: 24JBV655; 23) DYNJ19758I, UDI-DI: 10193489992328(each), 40193489992329(case), Lot Number: 24JBW212; 24) DYNJ24735F, UDI-DI: 10198459014277(each), 40198459014278(case), Lot Number: 24JBW301; 25) DYNJ41683B, UDI-DI: 10198459124112(each), 40198459124113(case), Lot Number: 24JBW466; 26) DYNJ39379C, UDI-DI: 10193489611526(each), 40193489611527(case), Lot Number: 24JBX574; 27) DYNJ64016B, UDI-DI: 10193489258363(each), 40193489258364(case), Lot Number: 24KBA541; 28) DYNJ68019A, UDI-DI: 10198459163937(each), 40198459163938(case), Lot Number: 24KBC477; 29) DYNJ69108A, UDI-DI: 10195327025717(each), 40195327025718(case), Lot Number: 24KBC478; 30) DYNJHTCLP101A, UDI-DI: 10080196980154(each), 40080196980155(case), Lot Number: 24KBC947; 31) DYNJ38147C, UDI-DI: 10193489854862(each), 40193489854863(case), Lot Number: 24KBF070; 32) DYNDA1841, UDI-DI: 10889942522286(each), 40889942522287(case), Lot Number: 24KBF305; 33) DYNJ41925I, UDI-DI: 10198459160516(each), 40198459160517(case), Lot Number: 24KBG148; 34) DYNJ81951B, UDI-DI: 10198459003615(each), 40198459003616(case), Lot Number: 24KBG626; 35) DYNJ19538F, UDI-DI: 10195327658137(each), 40195327658138(case), Lot Number: 24KBG632; 36) CDS982026V, UDI-DI: 10195327657635(each), 40195327657636(case), Lot Number: 24KBP804; 37) CDS982026V, UDI-DI: 10195327657635(each), 40195327657636(case), Lot Number: 24LBI154

510(k) numbers

not on file

PMA numbers

not on file

Product code

OEZ

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy