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Medline Convenience kits used for various procedures recallZ-1592-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 3, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1592-2025
Status
Open, Classified
Initiated by the company
Mar 3, 2025
Posted by the FDA
Apr 17, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
3205 units
Product code
OEZ
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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

Devices named in this recall

33 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96510).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page