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MEDICAL DEVICE RECALLCRITICAL
Namic Angiographic Manifold
Medline recalls Namic Angiographic Manifolds (SKU 64038200) due to particulate in the fluid path.
What to do
Stop using the affected manifolds immediately. Contact Medline Industries, LP for instructions on returning the product and obtaining a replacement or refund.
Why it was recalled
Medline is recalling Namic Angiographic Manifolds, custom, Medline Product Number/SKU 64038200, due to the presence of particulate within the fluid path of the manifolds. The particulate could be introduced into the patient's bloodstream during use, potentially causing serious adverse health consequences.
Is mine affected?
This recall covers 14 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B | 26CMC977 | Z-2146-2026 | 10889942814619, 40889942814610 |
| Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer | 89181, 95326, 95254, 102287, 102286, 102706, 105362, 105558, 108608, 112242, 112243, 115437, 118477, 121180, 121645, 122708, 126024, 131603, 136583, 140860, 142371, 146728, 147474, 148571, 152020, 153175, 163216, 175580, 176810, 184394, 191388, 193141 | Z-2141-2026 | 10193489059137, 30193489059131 |
| Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C | 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624 | Z-2148-2026 | 10193489475135, 40193489475136 |
| Medline medical convenience kits, containing Namic Manifold, Labeled as | 25DMA809, 23GBA252, 23HBI873, 23IBR043, 23KBF277, 24ABQ959, 25KMF194 | Z-2143-2026 | 10193489460872, 40193489460873, 10193489253146, 40193489253147, 10193489253146, 40193489253147, 10193489253146, 40193489253147, 10193489253146, 40193489253147, 10193489253146, 40193489253147, 10889942431922, 40889942431923 |
| 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: D | – | Z-2145-2026 | 60010195, 10193489040234, 30193489040238, 60010195, 10193489040234, 30193489040238, 60010195, 10193489040234, 30193489040238, 60010195, 10193489040234, 30193489040238, 60010195, 10193489040234, 30193489040238, 60010195, 10193489040234, 30193489040238, 60010195, 10193489040234 |
| 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 9. MTS,LEFT HEART,KIT, Medline Kit Number/S | – | Z-2144-2026 | 60010195, 10193489040234, 40193489040235, 60010195, 10193489040234, 40193489040235, 60010195, 10193489040234, 40193489040235, 60010195, 10193489040234, 40193489040235, 60010195, 10193489040234, 40193489040235, 60033123, 10193489042436, 40193489042437, 60033123, 10193489042436 |
| Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. | 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812 | Z-2139-2026 | 10193489059168, 30193489059162 |
| Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. | 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053 | Z-2138-2026 | 10193489059144, 30193489059148 |
Show all 14 products
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. | 92261, 152082, 163966, 163256 | Z-2140-2026 | 10193489059182, 30193489059186 |
| Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer | 117277, 119982, 122210, 122199, 130129, 133014, 136396, 138613, 139138, 157974, 162399, 164317, 175538, 193515, 193531 | Z-2142-2026 | 10193489059205, 30193489059209 |
| 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; | – | Z-2147-2026 | 60010508, 10193489040340, 40193489040341, 60010508, 10193489040340, 40193489040341, 60010508, 10193489040340, 40193489040341, 60010508, 10193489040340, 40193489040341, 60010508, 10193489040340, 40193489040341, 60010508, 10193489040340, 40193489040341, 60010508, 10193489040340 |
| 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. FEMORAL CARDIAC CATH, Medline Kit SKU Number: DYNJ66343A; 12. CARDIAC CATH PACK, Medline Kit SKU Number: DYNJ66693C; 13. TAVR PACK, Medline Kit SKU Number: DYNJ67225C; 14. AFIB TRAY, Medline Kit SKU Number: DYNJ85069; 15. AFIB TRAY, Medline Kit SKU Number: DYNJ85069A; 16. AFIB TRAY, Medline Kit SKU Number: DYNJ85069B; 17. MTO,LEFT HEART,KIT, Medline Kit SKU Number: VASC1811. Namic medical convenience kits, containing Namic Manifold, Labeled as: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS,4 VALVE,LFT,HRT,KIT, Medline Kit Number/SKU 60010468; 3. MTO,ADD,ON,KIT, Medline Kit Number/SKU 60010469; 4. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 5. MTS,LFT,HRT,KIT, Medline Kit Number/SKU 60012911; 6. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60012912; 7. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013001; 8. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013101; 9. MTS,LFT,HRT,W/WIRE, Medline Kit Number/SKU 60013112; 10. MTS,-,3V,KIT, Medline Kit Number/SKU 60020608; 11. MTO,ANGIO,KIT, Medline Kit Number/SKU 60032681; 12. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 13. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60033124; 14. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60034644; 15. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60040273; 16. MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 60040424; 17. MTS,3,VAVLE,KIT, Medline Kit Number/SKU 60041082; 18. MTS,2V,KIT, Medline Kit Number/SKU 60042453; 19. MTO,3V,KIT, Medline Kit Number/SKU 60042454; 20. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60042721; 21. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 22. MTS,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 60060268; 23. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60060564; 24. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60060569; 25. MTS, Medline Kit Number/SKU 60062021; 26. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60071232; 27. MTO,CATH,LAB,KIT, Medline Kit Number/SKU 60080221; 28. MTO,RIGHT, Medline Kit Number/SKU 60080347; 29. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 30. MTS,MANIFOLD,KIT, Medline Kit Number/SKU 60080716; 31. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60081001; 32. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60081002; 33. MTO,LEFT,HRT(RT,HANDED), Medline Kit Number/SKU 60081168; 34. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60090123; 35. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60091111; 36. MTS,EP,KIT, Medline Kit Number/SKU 60100056; 37. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 38. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60100339; 39. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60110273; 40. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60110701; 41. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60120693; 42. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60121817; 43. MTO,CATH,KIT, Medline Kit Number/SKU 60130124; 44. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60130318; 45. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 46. MTO,RT HEART,KIT, Medline Kit Number/SKU 60131323; 47. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 48. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131554; 49. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131815; 50. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60 | 91637, 91667, 92995, 95615, 97091, 102177, 104282, 108922, 110250, 89290, 91926, 98742, 100867, 103336, 112524, 120251, 123676, 126203, 133960, 135744, 140099, 142801, 144713, 146930, 149252, 152505, 155032, 159209, 163547, 168371, 173236, 173695, 177889, 180765, 185246, 103509, 105131, 141748, 146031, 172932 (+3659 more, see the official notice) | – | 10193489040234, 30193489040238, 10193489040319, 30193489040313, 10193489040326, 30193489040320, 10193489040340, 30193489040344, 10193489040685, 30193489040689, 10193489040692, 30193489040696, 10193489040715, 30193489040719, 10193489040746, 30193489040740, 10193489040753, 30193489040757, 10193489091236, 30193489091230, 10193489042351, 30193489042355, 10193489042436, 30193489042430, 10193489042443, 30193489042447, 10193489042580, 30193489042584, 10193489042832, 30193489042836, 10193489042900, 20193489042907, 10193489043006, 30193489043000, 10193489043150, 30193489043154, 10193489043167, 20193489043164, 10193489043174, 30193489043178 (+598 more, see the official notice) |
| Medline medical convenience kits, containing Namic Manifold, Labeled as | 23KBN009, 23LBI829, 24ABH036, 24BBG055, 24EBO156, 24GBS605, 24IBK765, 25ABR102, 25CBK686, 25DBR341, 25EBB568, 25FBB624, 25GBC747, 25HBF702, 25JBJ140, 26ABB718, 26BBI625, 23IBC156, 23KBB857, 24ABL640, 24CBD613, 24EBQ349, 26AMC406, 26CMA066, 25GBI702, 25GBQ931, 25JBG417, 25KBH544, 26AMC371, 26AMC433, 26CMC609, 26CMC660, 24GMH056, 24HMB740, 24JME459, 24KMJ018, 25AMG765, 25CME621, 25EMB706, 25EME362 (+58 more, see the official notice) | – | 10193489040340, 40193489040341, 10193489048872, 40193489048873, 10198459580918, 40198459580919, 10198459416590, 40198459416591, 10198459032981, 40198459032982, 10198459258633, 40198459258634, 10195327686499, 40195327686490, 10198459423758, 40198459423759, 10198459477218, 40198459477219, 10198459104299, 40198459104290, 10198459254727, 40198459254728, 10198459393327, 40198459393328, 10195327158699, 40195327158690, 10198459005640, 40198459005641, 10198459558689, 40198459558680, 10195327374198, 40195327374199, 10195327586157, 40195327586158 |
| 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 9. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60132238; 10. MTS,3,PORT,KIT, Medline Kit Number/SKU 60138301; 11. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60140589; 12. MTS,3 VALVE,W/, Medline Kit Number/SKU 60192012; 13. DBD-MTS,4V,MANIFOLD,KIT, Medline Kit Number/SKU 60220488; 14. MTS,LHK, Medline Kit Number/SKU 60232091; 15. MTO,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 65010037; 16. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65012819; 17. DBD-MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 65040421; 18. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65183482; 19. MTS KIM, Medline Kit Number/SKU 65660872; 20. LHK,-, Medline Kit Number/SKU 601006269; 21. DBD-MTS,MANIFOLD,KIT, Medline Kit Number/SKU 601203616; 22. MTO,4V,KIT, Medline Kit Number/SKU 650104611; 23. MTO,MANIFOLD,KIT, Medline Kit Number/SKU 651304116; 24. KIMAL 3 PORT RH OFF WITH CC PG, Medline Kit Number/SKU 656206837; 25. KIM MANIFOLD SET VER ONE - PG, Medline Kit Number/SKU 656608724; 26. CARDIAC MAN PG, Medline Kit Number/SKU 656608737; 27. MTO MANIFOLD, Medline Kit Number/SKU 656608739; 28. CARDIAC MANIFOLD SET, Medline Kit Number/SKU 656608749; 29. CARDIAC MAN SET, Medline Kit Number/SKU 656608753; 30. KIMAL 3 PORT MAN KIT, Medline Kit Number/SKU 656608755; 31. DBD-MTS,LHK, Medline Kit Number/SKU 6010236231; 32. LHK, Medline Kit Number/SKU 6561068101; 33. LHK, Medline Kit Number/SKU 60022681B; 34. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288O; 35. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288P; 36. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636M; 37. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922AA; 38. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922Y; 39. CATH PACK, Medline Kit Number/SKU DYNJ21810L; 40. CATH PACK, Medline Kit Number/SKU DYNJ21810M; 41. CATH PACK, Medline Kit Number/SKU DYNJ21810N; 42. CARDIAC CATH PACK W/ADD ON, Medline Kit Number/SKU DYNJ22553F; 43. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250F; 44. HEART CATH, Medline Kit Number/SKU DYNJ27274J; 45. HEART CATH, Medline Kit Number/SKU DYNJ27274K; 46. HEART CATH, Medline Kit Number/SKU DYNJ27274L; 47. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376G; 48. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376I; 49. CATH/ANGIO PACK, Medline Kit Number/SKU DYNJ38087G; 50. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333C; 51. CATH PACK, Medline Kit Number/SKU DYNJ44473C; 52. CATH PACK, Medline Kit Number/SKU DYNJ44473D; 53. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779F; 54. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615N; 55. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615O; 56. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615Q; 57. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947I; 58. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947J; 59. CARDIAC CATH LAB, Medline Kit Number/SKU DYNJ57748B; 60. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584F; 61. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584G; 62. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584I; 63. HEART ABLATION DRAPE PACK, Medline Kit Number/SKU DYNJ61984B; 64. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525B; 65. HMSL ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525C; 66. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548D; 67. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548F; 68. CATH LAB & E. P. PACK, Medline Kit Number/SKU DYNJ646 | 24CBF820, 24DBR149, 24HBO437, 24IBJ827, 25ABI082, 25BBI613, 25BBR862, 25DBC934, 25DBT579, 25FBF145, 25GBJ123, 25HBQ032, 25IBF219, 25JBS750, 25LBD357, 25ABW077, 25CBO600, 25DBR987, 25FBH978, 25IBF270, 25KBJ395, 24LBN469, 25CBA408, 25CBK717, 25EBF843, 25IBF307, 25KBA752, 26ABT007, 24LBT840, 25ABU494, 25BBR313, 25DBR517, 25EBB825, 25EBS427, 25FBT465, 25IBJ517, 25LBC673, 26BBF073, 23HBX390, 23IBD647 (+1180 more, see the official notice) | – | 10193489040234, 40193489040235, 10193489042436, 40193489042437, 10193489043273, 40193489043274, 10193489044539, 40193489044530, 10193489045062, 40193489045063, 10193489045383, 40193489045384, 10193489046458, 40193489046459, 10193489046809, 40193489046800, 10193489047233, 40193489047234, 10193489047639, 40193489047630, 10193489048032, 40193489048033, 10193489050929, 40193489050920, 10193489052527, 40193489052528, 10193489053258, 40193489053259, 10193489059502, 40193489059503, 10193489059687, 40193489059688, 10193489060416, 40193489060417, 10193489062823, 40193489062824, 10193489989557, 40193489989558, 10193489189582, 40193489189583 (+280 more, see the official notice) |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Medline Industries, LP
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification