CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
Medline Convenience kits used for various procedures recalled
Medline Industries LP - Northfield is recalling Medline Convenience kits used for various procedures: DR. Khan Cabg Adds Pack, distributed nationwide in the US. The recall was initiated on 3 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1592-2025
- FDA event ID
- 96510
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Mar 2025
- FDA classified
- 17 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Pacemakers & Defibrillators
Timeline
| 3 Mar 2025 | Recall initiated by company | |
| 17 Apr 2025 | Classified by FDA | +45 days |
| 23 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Questions about this recall
Why was it recalled?
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
33 other products · FDA event 96510This product is part of a recall event; the main page for the event is Medline Convenience kits used for various procedures: Nail Pack recalled.
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