Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2 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

Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 15) NEURO PACK, Model Number: DYNJ49098I; 16) NEURO PACK, Model Number: DYNJ53089B; 17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 20) NEURO PACK, Model Number: DYNJ60792B; 21) NEURO PACK, Model Number: DYNJ60792C; 22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 25) NEURO PACK, Model Number: DYNJ61740D; 26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 28) DISCECTOMY PACK, Model Number: DYNJ67835; 29) WWD NEURO PACK, Model Number: DYNJ80849B; 30) WWD NEURO PACK, Model Number: DYNJ80849J; 31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 32) NEURO, Model Number: DYNJ900904J; 33) NEURO, Model Number: DYNJ900904K; 34) NEURO, Model Number: DYNJ900904L; 35) NEURO, Model Number: DYNJ900904M; 36) NEURO, Model Number: DYNJ902585; 37) NEURO, Model Number: DYNJ902585A; 38) NEURO - IFCAP 230316, Model Number: DYNJ908393; 39) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 40) NEURO KIT, Model Number: DYNJ909573; 41) NEURO, Model Number: DYNJ910384; 42) NEURO, Model Number: DYNJ910384A; 43) NEURO PACK-LF, Model Number: PHS390015M

Lot/Code Info: 1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970; 2) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMD444; 3) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23AMJ086; 4) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22KMF991; 5) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22HMC764; 6) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22DMD555; 7) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21LMG598; 8) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21KMD971; 9) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21JMH357; 10) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMF497; 11) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GME436; 12) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMA403; 13) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21DBD719; 14) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21CBA213; 15) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24EMI161; 16) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24CMA817; 17) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23KMB758; 18) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMI786; 19) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMA572; 20) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23IME897; 21) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23GMC110; 22) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23EME270; 23) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22OBC508; 24) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22NBA962; 25) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22IBE871; 26) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBF303; 27) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBC967; 28) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBO542; 29) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBA074; 30) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22DBD203; 31) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22BBT015; 32) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21LBL164; 33) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21JBB951; 34) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21HBN643; 35) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBS468; 36) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBG761; 37) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21FBE311; 38) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21DBE120; 39) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBP552; 40) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBA521; 41) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABU817; 42) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABL131; 43) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBG852; 44) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBB221; 45) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABW870; 46) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABL138; 47) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24LBI083; 48) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBK044; 49) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBA532; 50) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24JBS893; 51) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24GBS072; 52) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24EBQ164; 53) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24DBJ890; 54) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBU410; 55) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBA173; 56) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24ABL221; 57) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23KBK072; 58) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23IBS183; 59) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23HBT876; 60) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23GBE625; 61) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23FBE493; 62) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23DBF392; 63) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBP083; 64) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBG764; 65) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23BBU041; 66) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23ABU154; 67) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22LBR466; 68) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22KBB452; 69) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22IBN422; 70) DYKMBNDL145, UDI-DI: 10193489478365(each), 40193489478366(case), Lot Number: 21ABT643; 71) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24HBF314; 72) DYKMBNDL5, UDI-DI: 10193489477634(each), 40193489477635(case), Lot Number: 21ABQ194; 73) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25KBQ729; 74) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25FBD172; 75) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25DBO558; 76) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25BBM404; 77) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBJ842; 78) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBH040; 79) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24GBK951; 80) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24EBC897; 81) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24DBJ607; 82) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24BBG003; 83) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23LBL844; 84) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23FBP269; 85) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23EBB597; 86) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23ABK051; 87) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 22IBJ928; 88) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23IBR967; 89) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23GBD741; 90) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23EBW271; 91) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23DBQ920; 92) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23CBI776; 93) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22OBL140; 94) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22LBL870; 95) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22JBL998; 96) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBO559; 97) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBF833; 98) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24DBT971; 99) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 23LBR942; 100) DYNJ0408776Y, UDI-DI: 10195327115852(each), 40195327115853(case), Lot Number: 23DBS739; 101) DYNJ04596K, UDI-DI: 10193489301342(each), 40193489301343(case), Lot Number: 23KMD949; 102) DYNJ35243L, UDI-DI: 10195327638733(each), 40195327638734(case), Lot Number: 24FMB808; 103) DYNJ49098I, UDI-DI: 10193489712100(each), 40193489712101(case), Lot Number: 21BBP868; 104) DYNJ53089B, UDI-DI: 10193489335248(each), 40193489335249(case), Lot Number: 21BBA722; 105) DYNJ53799, UDI-DI: 10889942444557(each), 40889942444558(case), Lot Number: 21ADA264; 106) DYNJ58704A, UDI-DI: 10193489502053(each), 40193489502054(case), Lot Number: 23CBT449; 107) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21KLA157; 108) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA398; 109) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA233; 110) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21GLB218; 111) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 22ABJ128; 112) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21FBS847; 113) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR913; 114) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR912; 115) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBO518; 116) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBJ319; 117) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21CBC497; 118) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23LBN124; 119) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23KBH242; 120) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23HBY836; 121) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23EBM305; 122) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23DBB793; 123) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23CBE668; 124) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22OBE182; 125) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22HBN525; 126) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23LBG606; 127) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23KBP559; 128) DYNJ61157D, UDI-DI: 10195327605919(each), 40195327605910(case), Lot Number: 24ABQ754; 129) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25KBL642; 130) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBR218; 131) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBG888; 132) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25ABG065; 133) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24IBQ689; 134) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24GBA833; 135) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24CBB175; 136) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBX534; 137) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBP375; 138) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22ABL607; 139) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBE011; 140) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB714; 141) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB713; 142) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21KBA371; 143) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21DBV445; 144) DYNJ61998, UDI-DI: 10193489615012(each), 40193489615013(case), Lot Number: 23EBV072; 145) DYNJ64570A, UDI-DI: 10195327242800(each), 40195327242801(case), Lot Number: 22LBK925; 146) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23GBG567; 147) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23FBJ662; 148) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23DBP210; 149) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBT224; 150) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBR140; 151) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23BBS499; 152) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22LBK279; 153) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22IBV281; 154) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22GBR040; 155) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22EBL897; 156) DYNJ80849B, UDI-DI: 10195327443689(each), 40195327443680(case), Lot Number: 23GBF525; 157) DYNJ80849J, UDI-DI: 10198459561245(each), 40198459561246(case), Lot Number: 25KBJ851; 158) DYNJ84653A, UDI-DI: 10195327697419(each), 40195327697410(case), Lot Number: 24GBU616; 159) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22OBE679; 160) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22KBC323; 161) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22JBY355; 162) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBR893; 163) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ992; 164) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ991; 165) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22ELA806; 166) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22EBB675; 167) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22CLA766; 168) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21LBG281; 169) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21JBQ824; 170) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21HBI172; 171) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21GBF913; 172) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25BME471; 173) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25AMG870; 174) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24LMD278; 175) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24KMG047; 176) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMF168; 177) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMB004; 178) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24HMA754; 179) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24FMF700; 180) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMH051; 181) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMB555; 182) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24CBN849; 183) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24ABH283; 184) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23KBH986; 185) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23JBF549; 186) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23HBQ501; 187) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23GBW505; 188) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBV444; 189) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBN975; 190) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABR127; 191) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABC415; 192) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25FMG005; 193) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMJ902; 194) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMG513; 195) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25DME524; 196) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25CMJ212; 197) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25HMI564; 198) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25GMI512; 199) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21GDB745; 200) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21FDA224; 201) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21EDA724; 202) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21CDB697; 203) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25DDB556; 204) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25ADA139; 205) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24LDA154; 206) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24JDC387; 207) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24GDA318; 208) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24CDA135; 209) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23IDB360; 210) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23FDA576; 211) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23ADA425; 212) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22IDA639; 213) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22HDB311; 214) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22GDB053; 215) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22FDB376; 216) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21LDA963; 217) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21JDC066; 218) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21IDB884; 219) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23GDA913; 220) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23FDB736; 221) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23EDB018; 222) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23BDB148; 223) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22LDA043; 224) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDB239; 225) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDA609; 226) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22HDC481; 227) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDB437; 228) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDA427; 229) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22EDA370; 230) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22BDB502; 231) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 23KDA234; 232) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25FLA327; 233) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25DLA489; 234) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24FBF785; 235) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24EBH096; 236) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25DBC086; 237) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF621; 238) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF584; 239) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25BBN770; 240) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25ABA025; 241) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 24JBQ224; 242) PHS390015M, UDI-DI: 10193489333824(each), 40193489333825(case), Lot Number: 20LMD456

Quantity Affected: 7494 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