See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Mod

Summary

The FDA issued a Class II for See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Nu by Medline Industries, LP. Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali.

Details

Product Description

See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;

Lot/Code Info: 1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 24ILB176; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 27) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 30) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23BLA242; 31) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23BLA602; 32) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23CLB259; 33) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 34) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23FLA144; 35) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23GLA152; 36) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23GLB213; 37) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23HLB120; 38) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ILA911; 39) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23LLA114; 40) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 24ALA030; 41) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24ALA755; 42) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24CLA098; 43) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24CLA726; 44) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24DLA309; 45) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24ELA365; 46) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24FLA779; 47) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24GLA640; 48) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24HLA954; 49) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24ILA464; 50) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24JLA176; 51) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 52) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24LLA151; 53) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 25CLA121; 54) CDS840087AM, UDI-DI: 10198459311611(each), 40198459311612(case), Lot Number: 25DLA768; 55) CDS840087AM, UDI-DI: 10198459311611(each), 40198459311612(case), Lot Number: 25ELA946; 56) CDS840087AM, UDI-DI: 10198459311611(each), 40198459311612(case), Lot Number: 25FLA689; 57) CDS840087AM, UDI-DI: 10198459311611(each), 40198459311612(case), Lot Number: 25GLA369; 58) CDS840087AM, UDI-DI: 10198459311611(each), 40198459311612(case), Lot Number: 25HLA612; 59) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21DBA306; 60) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21EBK732; 61) CDS840150T, UDI-DI: 10193489996197(each), 40193489996198(case), Lot Number: 21JBA896; 62) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22ABA269; 63) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22CBF996; 64) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22EBL398; 65) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22GBD762; 66) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22JBD465; 67) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22LBS336; 68) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23DBN632; 69) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23EBB628; 70) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23HBJ716; 71) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC675; 72) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC879; 73) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 24ABJ652; 74) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24CBQ331; 75) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24DBB189; 76) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24EBK094; 77) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP520; 78) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP521; 79) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24GBX352; 80) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24HBQ201; 81) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24JBX455; 82) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD200; 83) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD223; 84) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBR405; 85) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25CBD369; 86) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25DBL498; 87) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBD604; 88) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBT739; 89) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25HBT720; 90) CDS840246O, UDI-DI: 10198459095955(each), 40198459095956(case), Lot Number: 25BLA225; 91) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBL409; 92) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBX514; 93) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22IBE745; 94) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22KBO918; 95) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22OBA486; 96) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23ABG192; 97) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23DBE827; 98) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBF165; 99) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBQ953; 100) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23GBJ781; 101) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23JBM632; 102) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23LBK827; 103) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24ABB897; 104) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBF421; 105) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBK620; 106) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBU862; 107) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24FBS248; 108) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24GBQ632; 109) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24IBM204; 110) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24JBJ413; 111) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24LBK995; 112) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABA041; 113) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABU765; 114) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25CBO300; 115) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25EBF565; 116) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 117) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 118) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 119) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 120) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21CBG242; 121) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21HBO916; 122) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21IBO083; 123) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21KBQ156; 124) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE658; 125) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE659; 126) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22DBL431; 127) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF439; 128) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF451; 129) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG072; 130) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG077; 131) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG079; 132) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABF773; 133) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABG179; 134) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23BBG436; 135) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBN891; 136) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBQ865; 137) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 138) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 139) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 140) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 141) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 142) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 143) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 144) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 145) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 146) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 147) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 148) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 149) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 150) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21BBH224; 151) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21GBS209; 152) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22GLA269; 153) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22HBA238; 154) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22IBV957; 155) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22KBW189; 156) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23CBR891; 157) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBA214; 158) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBU791; 159) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24ABX492; 160) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24CBB817; 161) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24EBC679; 162) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24GBU141; 163) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24HBL828; 164) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24JBS428; 165) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBF438; 166) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBM940; 167) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25CBI244; 168) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25DBQ683; 169) CDS840451M, UDI-DI: 10195327417574(each), 40195327417575(case), Lot Number: 23LLA020; 170) CDS840455N, UDI-DI: 10195327390044(each), 40195327390045(case), Lot Number: 23JLA705; 171) CDS840455N, UDI-DI: 10195327390044(each), 40195327390045(case), Lot Number: 23JLA968; 172) CDS980839C, UDI-DI: 10193489723076(each), 40193489723077(case), Lot Number: 21FBB093; 173) CDS982048X, UDI-DI: 10195327110154(each), 40195327110155(case), Lot Number: 24AMJ211; 174) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 22LMI739; 175) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 23DMB917; 176) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 23FME399; 177) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 23IMB573; 178) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 23JMI183; 179) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24BMC371; 180) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24EMG641; 181) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24HMA337; 182) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24JMF683; 183) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25BMD423; 184) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25CMJ833; 185) CDS982566K, UDI-DI: 10193489435597(each), 40193489435598(case), Lot Number: 21CBQ731; 186) CDS982575K, UDI-DI: 10193489734799(each), 40193489734790(case), Lot Number: 21BKA040; 187) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21DKA457; 188) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21EKA064; 189) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21GBK054; 190) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBF470; 191) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBQ086; 192) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBQ075; 193) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBS146; 194) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22BBQ149; 195) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22DBI104; 196) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22EBL281; 197) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22FBF335; 198) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22GBM066; 199) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22IBU776; 200) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22JBP075; 201) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22LBS833; 202) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBL429; 203) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBT572; 204) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBL415; 205) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBU058; 206) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBF574; 207) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBT093; 208) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23IBP737; 209) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23KBK940; 210) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23LBS018; 211) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 24BBB783; 212) CDS982605K, UDI-DI: 10195327385750(each), 40195327385751(case), Lot Number: 23HBS732; 213) CDS982605K, UDI-DI: 10195327385750(each), 40195327385751(case), Lot Number: 23JBM287; 214) CDS982605K, UDI-DI: 10195327385750(each), 40195327385751(case), Lot Number: 23JBQ265; 215) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21CBK379; 216) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21DBP216; 217) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21EBC025; 218) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21FBF717; 219) CDS983376O, UDI-DI: 10195327169718(each), 40195327169719(case), Lot Number: 23BBM445; 220) CDS983376P, UDI-DI: 10195327343873(each), 40195327343874(case), Lot Number: 23CBJ647; 221) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23DBP240; 222) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23EBI730; 223) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23FBU833; 224) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23IBG370; 225) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23IBL265; 226) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23IBR206; 227) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23JBS275; 228) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23JBV929; 229) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 24AMB074; 230) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25CME797; 231) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DME288; 232) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DMH143; 233) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GME704; 234) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GMG706; 235) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25HMA016; 236) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25IMH581; 237) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMF022; 238) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMH340; 239) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 21FBF442; 240) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22HBI664; 241) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22IBD426; 242) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22KBI289; 243) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 23BBE439; 244) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21AKA832; 245) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21FMD794; 246) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21GMC871; 247) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21IMH924; 248) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21JMB643; 249) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21KMA019; 250) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21LMA822; 251) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22CMB854; 252) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22FMC683; 253) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMB738; 254) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMF199; 255) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22JMB563; 256) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22KMH072; 257) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23DMH027; 258) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23EMF372; 259) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23FMI141; 260) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMG766; 261) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMH171; 262) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23HMC461; 263) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23KMC560; 264) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24AMD733; 265) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24CME689; 266) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMB935; 267) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMG956; 268) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMC120; 269) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMF693; 270) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 24LMC522; 271) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25BMD134; 272) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25DMK316; 273) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25GMD056; 274) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25JME849; 275) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25KMI896; 276) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21BKA482; 277) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GBA694; 278) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GME785; 279) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21IMC057; 280) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMC359; 281) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMH819; 282) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22EBM615; 283) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22JBU821; 284) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22OBL943; 285) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23ABA881; 286) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23BBJ754; 287) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24KMC946; 288) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24LMC474; 289) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21BKA389; 290) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21DKA676; 291) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21EKA147; 292) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21FLA954; 293) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA057; 294) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA312; 295) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLB087; 296) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21HLA680; 297) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21ILA628; 298) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21KLB205; 299) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22ABF746; 300) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22EBL445; 301) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22FBX071; 302) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22HBL442; 303) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22IBT454; 304) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22JBT625; 305) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22LBQ630; 306) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22OBI364; 307) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23ABP719; 308) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBP065; 309) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBV540; 310) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23JBB129; 311) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23KBA264; 312) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23LBB141; 313) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBL931; 314) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBO822; 315) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24DBU415; 316) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24EBT292; 317) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24FBT233; 318) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24HBJ043; 319) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24IBH401; 320) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24JBM195; 321) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBA684; 322) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBN423; 323) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24LBA755; 324) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25BBR524; 325) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25CBG855; 326) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25FBD048; 327) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25GBY100; 328) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBB599; 329) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBC732; 330) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBL186; 331) CDS984355F, UDI-DI: 10888277770348(each), 40888277770349(case), Lot Number: 20LKB341; 332) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA352; 333) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA538; 334) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21EKA150; 335) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21FLA649; 336) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21GLA223; 337) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA499; 338) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA543; 339) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22BLA378; 340) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22FLA187; 341) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILA721; 342) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILB092; 343) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22JLB146; 344) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA544; 345) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA693; 346) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA569; 347) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA762; 348) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23HLA237; 349) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23ILB099; 350) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23JLA617; 351) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23LLA067; 352) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24BLA231; 353) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24ELA326; 354) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 25ALA777; 355) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 24LLA698; 356) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 25BLA015; 357) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 25CLA060; 358) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21ABE734; 359) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case),

Quantity Affected: 51061 units

Reason for Recall

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-01-07

Company