Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Enforcement
- Recall Number
- Z-2147-2026
- Event ID
- 98735
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 20, 2026
- Initiation Date
- March 24, 2026
- Classification Date
- May 8, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25EBB568; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25FBB624; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349; Medline Kit Number/SKU DYNJ04636N: UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26AMC406; Medline Kit Number/SKU DYNJ04636N: UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26CMA066; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBI702; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBQ931; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25JBG417; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25KBH544; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC371; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC433; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC609; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC660; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24GMH056; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24HMB740; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24JME459; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24KMJ018; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 25AMG765; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25CME621; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EMB706; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EME362; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25HME818; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25KME742; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 26AME732; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 26BME198; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24EMG321; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24GMA788; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24HMA312; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24IMI472; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24KMC197; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMC031; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMF563; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25CMI786; Medline Kit Number/SKU DYNJ50779G: UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25DMH709; Medline Kit Number/SKU DYNJ50779I: UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25GMF741; Medline Kit Number/SKU DYNJ50779I: UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25HME177; Medline Kit Number/SKU DYNJ50779I: UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25IME495; Medline Kit Number/SKU DYNJ50779I: UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25KMB250; Medline Kit Number/SKU DYNJ50779I: UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25LMC853; Medline Kit Number/SKU DYNJ50779I: UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 26CMD408; Medline Kit Number/SKU DYNJ56140C: UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 25HBV231; Medline Kit Number/SKU DYNJ56140C: UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 26ABK843; Medline Kit Number/SKU DYNJ56140C: UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 26CBE251; Medline Kit Number/SKU DYNJ62310C: UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24JMG837; Medline Kit Number/SKU DYNJ62310C: UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24JMH356; Medline Kit Number/SKU DYNJ62310C: UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24KMA339; Medline Kit Number/SKU DYNJ62310C: UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24KMC940; Medline Kit Number/SKU DYNJ62310D: UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25BMA421; Medline Kit Number/SKU DYNJ62310D: UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25BME140; Medline Kit Number/SKU DYNJ62310D: UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25CMH080; Medline Kit Number/SKU DYNJ62310D: UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25DMB438; Medline Kit Number/SKU DYNJ62310D: UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25EMA045; Medline Kit Number/SKU DYNJ62310F: UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25GMI604; Medline Kit Number/SKU DYNJ62310F: UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25HME419; Medline Kit Number/SKU DYNJ62310F: UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25JMF984; Medline Kit Number/SKU DYNJ62310F: UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25KMC303; Medline Kit Number/SKU DYNJ62310F: UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25KMJ733; Medline Kit Number/SKU DYNJ62310F: UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 26BMD977; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBE467; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBW249; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBW251; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23IBC125; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23KBJ681; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23KBT543; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23LBM984; Medline Kit Number/SKU DYNJ81911: UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 24BBR688; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24EBP711; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24GBP073; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24IBF171; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24KBH753; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24LBH071; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25ABM562; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25CBM896; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25FBJ466; Medline Kit Number/SKU DYNJ81911A: UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25HBJ125; Medline Kit Number/SKU DYNJT6544: UDI/DI each 10198459558689, UDI/DI case 40198459558680, Lot Number: 25KMF858; Medline Kit Number/SKU DYNJT6544: UDI/DI each 10198459558689, UDI/DI case 40198459558680, Lot Number: 26BMK015; Medline Kit Number/SKU NAM0015: UDI/DI each 10195327374198, UDI/DI case 40195327374199, Lot Number: 23GBQ457; Medline Kit Number/SKU SAMPC0706: UDI/DI each 10195327586157, UDI/DI case 40195327586158, Lot Number: 24ADA538.
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
21119 kits