Recall Z-1592-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1592-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-03

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-03-03. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-03-03
Firm location: Northfield, IL, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.