Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS9830 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) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174B; 12) KIT PEDS HEAD AND NECK, Model Number: DYKMBNDL196; 13) KIT OMF LEFORTE, Model Number: DYKMBNDL1A; 14) KIT OMF LEFORTE, Model Number: DYKMBNDL1B; 15) KIT OMF LEFORTE, Model Number: DYKMBNDL1C; 16) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32; 17) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32A; 18) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32B; 19) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66A; 20) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66B; 21) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88A; 22) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88B; 23) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88C; 24) KIT GEN SURG LAP VENTRA, Model Number: DYKMBNDL96C; 25) MINOR ENT PACK, Model Number: DYNJ01831I; 26) ENT BASIC PACK-LF, Model Number: DYNJ0387711F; 27) D AND C PACK-LF, Model Number: DYNJ0855090P; 28) CSS SINUS PACK, Model Number: DYNJ17005I; 29) CSS HEAD & NECK PACK, Model Number: DYNJ26780I; 30) NASALPLASTY #61-RF, Model Number: DYNJ27320V; 31) MASTOID PACK-WINTER PARK-LF, Model Number: DYNJ32060C; 32) T&A PACK, Model Number: DYNJ32809I; 33) HEAD AND NECK PACK, Model Number: DYNJ41169; 34) SIMPLE NECK DISSECTION, Model Number: DYNJ47481C; 35) ENT PACK, Model Number: DYNJ47882F; 36) ENT PACK, Model Number: DYNJ48401C; 37) ENT PACK, Model Number: DYNJ51934A; 38) PK,ORTHO-EXTREMITY-LOSROBLES, Model Number: DYNJ52916A; 39) HEAD & NECK PACK, Model Number: DYNJ54964A; 40) HEAD & NECK PACK, Model Number: DYNJ54964B; 41) ENT - MINOR ENT PACK-LF, Model Number: DYNJ56840B; 42) GLENNON HEAD AND NECK PACK-LF, Model Number: DYNJ57200C; 43) ENT PACK, Model Number: DYNJ57688F; 44) RF T AND A PACK, Model Number: DYNJ61393A; 45) T & A PACK, Model Number: DYNJ61935D; 46) ENT PACK, Model Number: DYNJ62093B; 47) ENT PACK, Model Number: DYNJ64024B; 48) OSCLJ HEAD AND NECK PACK, Model Number: DYNJ66509A; 49) HEAD AND NECK PACK, Model Number: DYNJ67208; 50) HEAD & NECK PACK, Model Number: DYNJ67328B; 51) PEDS HEAD AND NECK PACK, Model Number: DYNJ69746B; 52) NASAL PACK, Model Number: DYNJ81280A; 53) ENT-PLASTICS PACK, Model Number: DYNJ84258A; 54) ENT-PLASTICS PACK, Model Number: DYNJ84258B; 55) HEAD & NECK PACK, Model Number: DYNJ85078A; 56) ENT PACK, Model Number: DYNJ86194A; 57) EENT PACK, Model Number: DYNJ86235; 58) ENT PACK, Model Number: DYNJ87378; 59) ENT PACK, Model Number: DYNJ87378A; 60) ENT PACK, Model Number: DYNJ87378D; 61) ENT SPLIT PACK, Model Number: DYNJ87451; 62) ENT SINUS PACK, Model Number: DYNJ88498; 63) NASAL, Model Number: DYNJ902993F; 64) ENDO SINUS-MIDTOWN, Model Number: DYNJ905866; 65) T A, Model Number: DYNJ906292B; 66) THYROID, Model Number: DYNJ906841A; 67) THYROID - SMH AMB, Model Number: DYNJ907739B; 68) ENT, Model Number: DYNJ911623; 69) HEAD AND NECK PACK, Model Number: DYNJT5739; 70) RO MEDIASTINAL PACK-LF, Model Number: PHS393087007C

Lot/Code Info: 1) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399; 2) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21HBO921; 3) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22JBW315; 4) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22GBE731; 5) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22FBX804; 6) CDS983782C, UDI-DI: 10193489592047(each), 40193489592048(case), Lot Number: 21DKA756; 7) DYKE1456D, UDI-DI: 10195327639938(each), 40195327639939(case), Lot Number: 24CBK289; 8) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25HLA345; 9) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25FLA904; 10) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25DLB145; 11) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25CLB002; 12) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24DLA606; 13) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24ALA266; 14) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBS478; 15) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBO537; 16) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21DBJ855; 17) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21CBD340; 18) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21BBG062; 19) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21ABK323; 20) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22GBH498; 21) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22FBT038; 22) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22EBS812; 23) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22DBL428; 24) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22CBX230; 25) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22BBA231; 26) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22ABG015; 27) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBB014; 28) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBA009; 29) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21IBP624; 30) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21HBF494; 31) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21GBE737; 32) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25GBX739; 33) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25EBH975; 34) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25DBQ008; 35) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25BBM402; 36) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25ABK769; 37) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24KBJ157; 38) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24HBU706; 39) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBR935; 40) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBD477; 41) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24EBF125; 42) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24DBV609; 43) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24ABL113; 44) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBT911; 45) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBQ487; 46) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBV381; 47) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBT877; 48) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23FBG212; 49) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23EBS366; 50) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23DBM060; 51) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23ABQ109; 52) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22KBH786; 53) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22IBU647; 54) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21FBQ554; 55) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21BBP836; 56) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21ABH824; 57) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22EBO543; 58) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22BBS429; 59) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 21LBY299; 60) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 25LBM606; 61) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24EBP260; 62) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24DBB691; 63) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24CBA389; 64) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23JBN238; 65) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23ABH675; 66) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22LBI002; 67) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22KBK464; 68) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBT411; 69) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBS041; 70) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBM511; 71) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBH559; 72) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBF521; 73) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21BBG851; 74) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21ABP337; 75) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 23BLA884; 76) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22KLA452; 77) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22JLB001; 78) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA924; 79) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA791; 80) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25DLA251; 81) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25CLA312; 82) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25BLA837; 83) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24JLA055; 84) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24ILA560; 85) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLB156; 86) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLA924; 87) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24GLA055; 88) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24FLA349; 89) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23LLA422; 90) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23KLA620; 91) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23JLA058; 92) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23ILA756; 93) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23HLA624; 94) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23DLA495; 95) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23CLA769; 96) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA386; 97) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA035; 98) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA843; 99) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA232; 100) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA179; 101) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21FBT798; 102) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21EBM706; 103) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21DBK216; 104) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21CBS031; 105) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21BBL111; 106) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ985; 107) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ862; 108) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22HBP925; 109) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBQ602; 110) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBF522; 111) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22FBE193; 112) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBQ053; 113) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBO633; 114) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21JBJ743; 115) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21IBD784; 116) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBP188; 117) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBC830; 118) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24EBU213; 119) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24DBU451; 120) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24CBR483; 121) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABK306; 122) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABH039; 123) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23LBP166; 124) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23IBA611; 125) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBX217; 126) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBH678; 127) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23FBP266; 128) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBT500; 129) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBB247; 130) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23DBP706; 131) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23BBS356; 132) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 22JBW957; 133) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 22IBL167; 134) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24DBD514; 135) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24CBD159; 136) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24BBT350; 137) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 23LBF184; 138) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22LBN128; 139) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBQ673; 140) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBG017; 141) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25LBI754; 142) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25JBF754; 143) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25CBR258; 144) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25ABH117; 145) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24LBT153; 146) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24KBT017; 147) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24IBO509; 148) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24HBH734; 149) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24FBG015; 150) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24DBR155; 151) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBN843; 152) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBJ801; 153) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23ABK217; 154) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22LBR829; 155) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBW066; 156) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBD610; 157) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25FBT988; 158) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBU506; 159) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBK536; 160) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25CBI877; 161) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABS392; 162) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABH118; 163) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBX567; 164) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBL602; 165) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBU190; 166) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBN944; 167) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBU598; 168) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBF126; 169) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24DBS395; 170) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBL266; 171) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBJ842; 172) DYKMBNDL88C, UDI-DI: 10198459584886(each), 40198459584887(case), Lot Number: 25LBP011; 173) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 25GBG516; 174) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24KBA441; 175) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24IBQ080; 176) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBN645; 177) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBJ497; 178) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24GBH580; 179) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24DBR908; 180) DYNJ01831I, UDI-DI: 10889942572502(each), 40889942572503(case), Lot Number: 21EMA909; 181) DYNJ0387711F, UDI-DI: 10198459005893(each), 40198459005894(case), Lot Number: 24HMA304; 182) DYNJ0855090P, UDI-DI: 10198459605826(each), 40198459605827(case), Lot Number: 25LMA083; 183) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 23HBV662; 184) DYNJ26780I, UDI-DI: 10193489238822(each), 40193489238823(case), Lot Number: 23GBP197; 185) DYNJ27320V, UDI-DI: 10195327104719(each), 40195327104710(case), Lot Number: 22LBQ654; 186) DYNJ32060C, UDI-DI: 10884389637265(each), 40884389637266(case), Lot Number: 22LBS348; 187) DYNJ32809I, UDI-DI: 10193489448795(each), 40193489448796(case), Lot Number: 22IBP091; 188) DYNJ41169, UDI-DI: 10884389906699(each), 40884389906690(case), Lot Number: 22LBR515; 189) DYNJ47481C, UDI-DI: 10889942544028(each), 40889942544029(case), Lot Number: 21BBP023; 190) DYNJ47882F, UDI-DI: 10195327319472(each), 40195327319473(case), Lot Number: 23HME434; 191) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25ABD063; 192) DYNJ51934A, UDI-DI: 10193489584776(each), 40193489584777(case), Lot Number: 23HMG725; 193) DYNJ52916A, UDI-DI: 10195327311735(each), 40195327311736(case), Lot Number: 24GMK024; 194) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25DBB366; 195) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25BBM674; 196) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24LBN788; 197) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24IBV894; 198) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25KBH303; 199) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25HBR203; 200) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 22GBJ777; 201) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ699; 202) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ696; 203) DYNJ57200C, UDI-DI: 10198459306754(each), 40198459306755(case), Lot Number: 25EMA242; 204) DYNJ57688F, UDI-DI: 10195327034610(each), 40195327034611(case), Lot Number: 22HMH769; 205) DYNJ61393A, UDI-DI: 10193489444179(each), 40193489444170(case), Lot Number: 23CMB523; 206) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBK459; 207) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBI869; 208) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23LBP950; 209) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23HBC470; 210) DYNJ62093B, UDI-DI: 10193489969351(each), 40193489969352(case), Lot Number: 23ABE410; 211) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24KBS794; 212) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24HBO119; 213) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24EBS530; 214) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24DBV691; 215) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24ABK239; 216) DYNJ66509A, UDI-DI: 10193489462708(each), 40193489462709(case), Lot Number: 24HMA316; 217) DYNJ67208, UDI-DI: 10193489391671(each), 40193489391672(case), Lot Number: 20XBA769; 218) DYNJ67328B, UDI-DI: 10195327271503(each), 40195327271504(case), Lot Number: 23HMD036; 219) DYNJ69746B, UDI-DI: 10195327475222(each), 40195327475223(case), Lot Number: 24JLA247; 220) DYNJ81280A, UDI-DI: 10195327491284(each), 40195327491285(case), Lot Number: 25LME467; 221) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24HBK264; 222) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24DBR594; 223) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBI987; 224) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBF775; 225) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25FBL492; 226) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25EBG049; 227) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBP146; 228) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBD271; 229) DYNJ85078A, UDI-DI: 10195327532543(each), 40195327532544(case), Lot Number: 24HMA736; 230) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24DBN706; 231) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 25LMD475; 232) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24IBL260; 233) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24HBV552; 234) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24CBG395; 235) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24HMA738; 236) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24GMG790; 237) DYNJ87378A, UDI-DI: 10198459186394(each), 40198459186395(case), Lot Number: 24KMI285; 238) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25JMI380; 239) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMC112; 240) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMA065; 241) DYNJ87451, UDI-DI: 10198459040283(each), 40198459040284(case), Lot Number: 24HBH452; 242) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMF610; 243) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMC641; 244) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMD509; 245) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMA480; 246) DYNJ905866, UDI-DI: 10193489547184(each), 40193489547185(case), Lot Number: 23CBW319; 247) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24CBI703; 248) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24BBV224; 249) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21HBN905; 250) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBR282; 251) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBG669; 252) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABP522; 253) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABE814; 254) DYNJ911623, UDI-DI: 10198459441097(each), 40198459441098(case), Lot Number: 25HBH612; 255) DYNJT5739, UDI-DI: 10198459499661(each), 40198459499662(case), Lot Number: 25IMF120; 256) PHS393087007C, UDI-DI: 10193489222777(each), 40193489222778(case), Lot Number: 21ADA448

Quantity Affected: 9051 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