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Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: ...

FDA Device Recall #Z-1592-2025 — Class II — March 3, 2025

Recall Summary

Recall Number Z-1592-2025
Classification Class II — Moderate risk
Date Initiated March 3, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 3205 units

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

Reason for Recall

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

Distribution Pattern

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

Lot / Code Information

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

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

Recall # Classification Product Date
Z-2567-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2566-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2479-2025 Class II Medline Kits containing BD SureStep Foley Tray ... Jul 23, 2025
Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
Z-2452-2025 Class II The Medline General Surgery Tray is customized ... Jul 8, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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