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Recall Observatory FDA recall evidence

Device product

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

Z-2144-2026

March 24, 2026

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 98735
Status
Ongoing
Classification
Class I
Quantity
322460 kits
Official record key
device-enforcement:Z-2144-2026

Official wording

Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.

Code information: Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24CBF820; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24DBR149; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24HBO437; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24IBJ827; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 25ABI082; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25BBI613; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25BBR862; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25DBC934; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25DBT579; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25FBF145; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25GBJ123; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25HBQ032; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25IBF219; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25JBS750; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25LBD357; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25ABW077; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25CBO600; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25DBR987; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25FBH978; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25IBF270; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25KBJ395; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 24LBN469; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25CBA408; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25CBK717; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25EBF843; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25IBF307; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25KBA752; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 26ABT007; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 24LBT840; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25ABU494; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25BBR313; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25DBR517; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25EBB825; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25EBS427; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25FBT465; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25IBJ517; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25LBC673; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 26BBF073; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23HBX390; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23IBD647; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23LBC207; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24ABK892; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24DBA937; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24DBJ585; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24EBE043; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24IBN995; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24IBO100; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24LBO436; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25CBH999; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25CBT160; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25DBR989; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25FBD599; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25HBN775; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25JBM965; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25LBH604; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25LBS225; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 26BBJ154; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 23LBD402; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 23LBS016; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24ABD855; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24BBG034; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24BBM144; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24CBO038; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24CBO214; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24DBK642; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24KBN940; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25BBS815; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25CBG643; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25CBU110; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25EBC252; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25FBF616; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25FBK959; Medline Kit Number/SKU 60131324: UDI/DI each 10193489046809, UDI/DI case 40193489046800, Lot Number: 24KBN354; Medline Kit Number/SKU 60131324: UDI/DI each 10193489046809, UDI/DI case 40193489046800, Lot Number: 24KBN941; Medline Kit Number/SKU 60131324: UDI/DI each 10193489046809, UDI/DI case 40193489046800, Lot Number: 24LBT120; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 24BBR657; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 24CBA189; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 24FBM887; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25ABG502; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25ABV176; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25BBR314; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25CBI001; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25CBL913; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25CBO416; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25DBV071; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25EBC051; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25EBE549; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25IBT687; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25IBU966; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25KBB948; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 26ABM807; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 26BBL416; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 26CBH011; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25ABF936; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25ABR903; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25BBI319; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25BBQ787; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25DBO069; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25EBP376; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25HBC010; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25JBA192; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25LBA490; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 26BBJ144; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 24LBQ695; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25ABQ318; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25EBB629; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25FBE410; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25FBO675; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25HBL092; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25IBM684; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25KBJ830; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 26ABN648; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 24LBL633; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 24LBT384; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25CBQ237; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25EBH401; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25GBX825; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25HBL094; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26ABC178; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26ABF962; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26BBN954; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26CBB706; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 23LBC519; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 23LBC520; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 23LBD120; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24BBL703; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24CBM350; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24CBM351; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24HBS750; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24JBC085; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25FBE411; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25GBS552; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25IBN368; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25JBI441; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25JBX630; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25LBC407; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 26BBB138; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25CBD801; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25CBK055; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25CBP471; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25DBR961; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25EBD424; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25FBE633; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25FBJ631; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25GBC837; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25GBN114; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25GBW454; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25HBD429; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25IBF794; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25JBL011; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25KBO033; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25KBT052; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25LBC283; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25LBF571; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25CBL361; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25DBQ337; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25EBN624; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25FBE412; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25FBN083; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25GBD061; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25IBG953; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25KBO724; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25KBS323; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 26ABC753; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 26ABR022; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 24KBT591; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 24LBE978; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25DBQ343; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25DBT925; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25EBJ331; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25EBN550; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25EBU247; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25FBE413; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25FBF761; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25HBA587; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25JBL132; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25JBR927; Medline Kit Number/SKU 65183482: UDI/DI each 10193489062823, UDI/DI case 40193489062824, Lot Number: 23LBV434; Medline Kit Number/SKU 65183482: UDI/DI each 10193489062823, UDI/DI case 40193489062824, Lot Number: 24CBB755; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 23KBJ803; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 23LBC925; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 23LBP705; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24BBK267; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24DBU989; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24GBT179; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24IBL496; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24JBA690; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24KBI563; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24KBN943; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24KBQ269; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24LBJ407; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24LBO500; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25ABB054; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25BBI520; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25CBL739; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25CBT917; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25DBA597; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25FBQ181; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25FBS611; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25HBL493; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25IBI773; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25IBT228; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25LBI277; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 23KBW790; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24BBG011; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24BBV062; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24EBH524; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24FBD353; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24GBT409; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24GBT418; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24JBX239; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24KBL357; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24KBL665; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24KBR053; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24LBB805; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25CBN927; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25EBA296; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25FBN589; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25IBF118; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25IBV472; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 26ABA296; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 26ABM374; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 26BBO252; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 23LBN507; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24BBD883; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24CBP951; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24FBS128; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24HBL889; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24HBW911; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 24LBO506; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25ABL641; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25BBM277; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25CBL017; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25CBN644; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25CBS021; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25EBG284; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25FBI559; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25GBC062; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25GBN092; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25HBG211; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25IBA166; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25IBR553; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBA722; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBJ009; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBL024; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBX186; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25KBH488; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25LBM779; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25LBM780; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABG265; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABR490; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABR491; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABR492; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABU629; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBF384; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBI348; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBL421; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBT130; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26CBA497; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25BBD354; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25BBI530; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25CBD811; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25CBL374; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25DBQ359; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25EBJ265; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25EBU808; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25EBV383; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBG209; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBH353; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBN115; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBV470; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBW455; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBX436; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25JBU837; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25KBR043; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25LBT349; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 26ABE723; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23JBN268; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23KBJ916; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23LBC919; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23LBI119; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24ABI603; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24BBI553; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24DBK464; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24GBT178; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24HBI912; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24IBA808; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 4019348999

Distribution pattern: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate