FDA Device recall Z-1592-2025
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D by Medline Industries Northfield, citing there is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1592-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-03 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
Reason
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Identifiers
| code_info | 1) DYNJ59310D, UDI-DI: 10195327402396(each), 40195327402397(case), Lot Number: 24IBB643; 2) DYNJ32436A, UDI-DI: 1088438…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1592-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.