Medline Convenience kits used for various procedures: 1) DR — Class II medical device recall Z-1592-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-23, distributed nationwide. There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile co
| Recall number | Z-1592-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-03-03 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, PA |
| Quantity | 3,205 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10080196980154, 10193489203509, 10193489258363, 10193489471991, 10193489611526, 10193489646924, 10193489663235, 10193489712469, 10193489854862, 10193489957358, 10193489992328, 10195327012014, 10195327016104, 10195327025717, 10195327373597, 10195327402396, 10195327428914, 10195327429744, 10195327478056, 10195327573812, 10195327628703, 10195327657635, 10195327658137, 10198459003615, 10198459014277 and 41 more |
| Lot numbers | 24IBB643, 24IBG295, 24IBG343, 24IBG535, 24IBH248, 24IBH653, 24IBL194, 24IBO308, 24IBT180, 24IBV182, 24JBL521, 24JBM305, 24JBM849, 24JBM893, 24JBM959, 24JBT045, 24JBU078, 24JBU113, 24JBU159, 24JBU436, 24JBV115, 24JBV655, 24JBW212, 24JBW301, 24JBW466, 24JBX574, 24KBA541, 24KBC477, 24KBC478, 24KBC947, 24KBF070, 24KBF305, 24KBG148, 24KBG626, 24KBG632, 24KBP804, 24LBI154 |
| Model numbers | CDS982026V, DYNDA1841, DYNJ19538F, DYNJ19758I, DYNJ24735F, DYNJ25102I, DYNJ27949F, DYNJ32436A, DYNJ35586G, DYNJ38147C, DYNJ39111A, DYNJ39379C, DYNJ40480, DYNJ41683B, DYNJ41874C, DYNJ41925I, DYNJ43278C, DYNJ48196C, DYNJ55343B, DYNJ56729, DYNJ59310D, DYNJ62339, DYNJ64016B, DYNJ65027B, DYNJ68019A and 8 more |
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 for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1592-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.