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Recall Observatory FDA recall evidence

Device product

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

Z-2145-2026

March 24, 2026

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 98735
Status
Ongoing
Classification
Class I
Quantity
567675 kits
Official record key
device-enforcement:Z-2145-2026

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 30193489040238, Lot Number: 91637; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91667; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 92995; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 95615; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 97091; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 102177; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 104282; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 108922; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 110250; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 89290; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 91926; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 98742; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 100867; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 103336; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 112524; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 120251; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 123676; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 126203; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 133960; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 135744; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 140099; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 142801; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 144713; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 146930; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 149252; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 152505; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 155032; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 159209; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 163547; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 168371; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 173236; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 173695; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 177889; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 180765; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 185246; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 103509; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 105131; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 141748; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 146031; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 172932; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 180179; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 180226; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 185514; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 101553; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 103798; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 122264; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 91220; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 91833; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 95789; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 97737; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 104805; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 106258; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 114948; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 115856; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 129215; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 129501; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 131536; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 138730; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 143661; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 144820; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 145579; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 148112; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 150651; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 176144; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 188261; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 104011; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 119986; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 120336; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 122652; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 130946; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 149576; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 152390; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 153237; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 162759; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 164896; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 188361; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 93782; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 96363; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 97380; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 98743; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 105137; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 106046; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 111206; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 114190; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 115831; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 118695; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 123787; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 128251; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 133072; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 138228; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 140367; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 144535; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 149547; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 152488; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 155300; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 162783; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 166461; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 168363; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 168433; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 88809; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 93807; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 98370; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 102015; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 104687; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 107324; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 109984; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 116869; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 124230; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 129398; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 133867; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 156445; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 156915; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 160817; Medline Kit Number/SKU 60013112: UDI/DI each 10193489040753, UDI/DI case 30193489040757, Lot Number: 110228; Medline Kit Number/SKU 60013112: UDI/DI each 10193489040753, UDI/DI case 30193489040757, Lot Number: 112533; Medline Kit Number/SKU 60013112: UDI/DI each 10193489040753, UDI/DI case 30193489040757, Lot Number: 161094; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 91836; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 97142; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 98744; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 102810; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 105641; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 110931; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 114188; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 119364; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 122277; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 123026; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 130849; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 131983; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 136561; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 138724; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 140812; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 148499; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 151382; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 154050; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 159730; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 161133; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 165637; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 168673; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 169864; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 174919; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 178181; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 179538; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 182044; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 188260; Medline Kit Number/SKU 60032681: UDI/DI each 10193489042351, UDI/DI case 30193489042355, Lot Number: 91621; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 90165; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 92346; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 94178; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 95748; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 97899; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 98731; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 101209; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 104020; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 105502; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 109602; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 114204; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 118543; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 118554; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 118685; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 124471; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 127944; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 131860; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 133868; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 139244; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 141280; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 145234; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 149064; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 98710; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 114002; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 117653; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 152098; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 156448; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 157222; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 161918; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 89558; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 109996; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 118697; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 132131; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 145960; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 154989; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 176185; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 192611; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 93733; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 95366; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 97021; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 97144; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 98758; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 100158; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 100285; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 103508; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 106037; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 115791; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 115938; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 118192; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 123857; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 128244; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 132367; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 133069; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 137490; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 140896; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 145545; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 148439; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 149175; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 153015; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 154538; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 162383; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 169029; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 171860; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 172058; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 179872; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 183375; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 187369; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 188866; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 189915; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 96014; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 97846; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 116943; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 119653; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 137248; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 141314; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 160096; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 169412; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 170710; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 176826; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 179557; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 181885; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 188252; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 188731; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 194036; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 89747; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 90431; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 93432; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 95362; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 99945; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 99946; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 102173; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 111165; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 113255; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 115375; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 115727; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 118600; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 90432; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 114640; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 114693; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 156827; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 162761; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 184028; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 184433; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 103077; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 105514; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 129200; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 130614; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 161885; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 163536; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 174742; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 175617; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 181137; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 91826; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 94859; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 109994; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 115796; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 118026; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 124170; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 137944; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 145441; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 153696; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 158858; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 162927; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 167645; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 173222; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 87997; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 91709; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 93429; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 98728; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 99066; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 106096; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 108172; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 115717; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 115718; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 116439; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 120538; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 126638; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 128698; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 130991; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 131369; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 135363; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 148880; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 89836; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 101173; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 107517; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 114651; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 116405; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 120766; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 157701; Medline Kit Number/

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