Medline Industries, LP

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.

Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 12) MINOR EYE PACK, Model Number: DYNJ17219C; 13) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 14) EYE PACK, Model Number: DYNJ41207C; 15) OPHTHALMIC PACK, Model Number: DYNJ42043I; 16) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 17) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 18) EYE PLASTIC PACK, Model Number: DYNJ47859B; 19) EYE PLASTIC PACK, Model Number: DYNJ47859C; 20) CATARACT PACK, Model Number: DYNJ53019A; 21) CATARACT PACK, Model Number: DYNJ54869A; 22) VITRECTOMY PACK, Model Number: DYNJ55280B; 23) NDNW-EYE PACK, Model Number: DYNJ61779C; 24) EYE PK, Model Number: DYNJ62306; 25) VITRECTOMY, Model Number: DYNJ64220; 26) OSC BREAST PACK, Model Number: DYNJ65808C; 27) MILLS CATARACT PACK, Model Number: DYNJ67973A; 28) EYE PACK, Model Number: DYNJ68367B; 29) CATARACT PACK, Model Number: DYNJ68875D; 30) CATARACT PACK, Model Number: DYNJ68875F; 31) CATARACT PACK, Model Number: DYNJ68875G; 32) VITRECTOMY IP, Model Number: DYNJ84020; 33) PLASTIC PACK, Model Number: DYNJ86288; 34) OPHTHO PLASTIC, Model Number: DYNJ902256C; 35) RETINAL, Model Number: DYNJ907495; 36) CATARACT, Model Number: DYNJ909924; 37) CATARACT, Model Number: DYNJ909924A; 38) COMBO EYE, Model Number: DYNJ909925; 39) VITRECTOMY, Model Number: DYNJ909929; 40

1) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21ABV400; 2) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21FBP706; 3) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21IBV636; 4) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 22GBP895; 5) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22HBX475; 6) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS899; 7) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS907; 8) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22KBO773; 9) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 23HBV380; 10) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 24EBU650; 11) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 25HBK503; 12) DYKMBNDL159, UDI-DI: 10193489478273(each), 40193489478274(case), Lot Number: 21ABQ655; 13) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21ABT655; 14) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21BBM375; 15) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21FBP773; 16) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ABR620; 17) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21BBK655; 18) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21FLA394; 19) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21HLA179; 20) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ILA655; 21) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21KLA277; 22) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23CBP086; 23) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23DBD264; 24) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23CBP088; 25) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23EBL613; 26) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23FBU438; 27) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23GBE628; 28) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23IBA614; 29) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23JBK353; 30) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23KBJ008; 31) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23LBI221; 32) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24ABH891; 33) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24BBJ841; 34) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24CBA180; 35) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24EBF870; 36) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24HBS367; 37) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21ABT657; 38) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21DBC009; 39) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21GBJ364; 40) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 21IBP918; 41) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW517; 42) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW535; 43) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22FBB999; 44) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22GBW969; 45) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22OBC233; 46) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBC619; 47) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBT177; 48) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBA356; 49) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBD243; 50) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 24FBB728; 51) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBJ362; 52) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBU487; 53) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25EBG033; 54) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 23JBA703; 55) DYNJ17219C, UDI-DI: 10888277053007(each), 40888277053008(case), Lot Number: 21ADA445; 56) DYNJ38791M, UDI-DI: 10193489665437(each), 40193489665438(case), Lot Number: 23EBS726; 57) DYNJ41207C, UDI-DI: 10195327353063(each), 40195327353064(case), Lot Number: 23KMH083; 58) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21BMA716; 59) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21CMA770; 60) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21DMA925; 61) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21GMA744; 62) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21HMC573; 63) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21GMD097; 64) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21HMB926; 65) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21IMH317; 66) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21JMF395; 67) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22AMC045; 68) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22BMD451; 69) DYNJ45585C, UDI-DI: 10195327475512(each), 40195327475513(case), Lot Number: 23IBE143; 70) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21CBJ926; 71) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21DBQ717; 72) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21FBM463; 73) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21JBG678; 74) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22ABJ996; 75) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22EBT342; 76) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22JBS972; 77) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23CBC335; 78) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBA347; 79) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBE835; 80) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23GBD486; 81) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23KBB813; 82) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24ABB652; 83) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24EBT972; 84) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24FBI469; 85) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24KBA576; 86) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25ABK875; 87) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25BBT529; 88) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25FBE320; 89) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25GBQ388; 90) DYNJ53019A, UDI-DI: 10889942582761(each), 40889942582762(case), Lot Number: 21ADA466; 91) DYNJ54869A, UDI-DI: 10889942606085(each), 40889942606086(case), Lot Number: 20XBF509; 92) DYNJ55280B, UDI-DI: 10193489919806(each), 40193489919807(case), Lot Number: 21GDB817; 93) DYNJ61779C, UDI-DI: 10195327379643(each), 40195327379644(case), Lot Number: 23EBQ641; 94) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21FBJ619; 95) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21GBG219; 96) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21JBD854; 97) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21KBM947; 98) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22ABU477; 99) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22DBS613; 100) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22EBO615; 101) DYNJ64220, UDI-DI: 10193489794618(each), 40193489794619(case), Lot Number: 21ABW916; 102) DYNJ65808C, UDI-DI: 10195327369064(each), 40195327369065(case), Lot Number: 23KMB340; 103) DYNJ67973A, UDI-DI: 10193489437386(each), 40193489437387(case), Lot Number: 22JBK486; 104) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23CMA209; 105) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23FMI783; 106) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23GMB569; 107) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23JMF562; 108) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23LMG710; 109) DYNJ68875D, UDI-DI: 10195327335076(each), 40195327335077(case), Lot Number: 23BBP426; 110) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23FBQ273; 111) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23GBS486; 112) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23HBP752; 113) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23IBO012; 114) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 23LBK778; 115) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24BBG704; 116) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24CBN385; 117) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24FBR482; 118) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24IBM141; 119) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24JBT066; 120) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24KBA594; 121) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25ABO204; 122) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25DBC415; 123) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25DBS882; 124) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25GBB923; 125) DYNJ84020, UDI-DI: 10195327327002(each), 40195327327003(case), Lot Number: 23GBU083; 126) DYNJ86288, UDI-DI: 10195327615468(each), 40195327615469(case), Lot Number: 24DBL612; 127) DYNJ86288, UDI-DI: 10195327615468(each), 40195327615469(case), Lot Number: 24EBM019; 128) DYNJ902256C, UDI-DI: 10195327089368(each), 40195327089369(case), Lot Number: 22FDA445; 129) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 21CDB771; 130) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 22KDB104; 131) DYNJ909924, UDI-DI: 10195327506728(each), 40195327506729(case), Lot Number: 23LBJ479; 132) DYNJ909924A, UDI-DI: 10198459182754(each), 40198459182755(case), Lot Number: 24KBT165; 133) DYNJ909925, UDI-DI: 10195327506735(each), 40195327506736(case), Lot Number: 23LBJ480; 134) DYNJ909925, UDI-DI: 10195327506735(each), 40195327506736(case), Lot Number: 24KBH632; 135) DYNJ909929, UDI-DI: 10195327506759(each), 40195327506750(case), Lot Number: 23LBJ481; 136) DYNJ909929, UDI-DI: 10195327506759(each), 40195327506750(case), Lot Number: 24KBM022; 137) DYNJC2364O, UDI-DI: 10193489908091(each), 40193489908092(case), Lot Number: 23JBJ429