Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TO

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL 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) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65

Lot/Code Info: 1) CDS940087AG, UDI-DI: 10193489847260(each), 40193489847261(case), Lot Number: 21EBC900; 2) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22GBE442; 3) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBG548; 4) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBF695; 5) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBA274; 6) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22BBY060; 7) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21KBH163; 8) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21JBF936; 9) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21IBJ260; 10) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21GBI183; 11) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21FBS254; 12) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21BBL223; 13) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21LBO219; 14) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBQ650; 15) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBB625; 16) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBV695; 17) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBU197; 18) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21GBR895; 19) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23JBI054; 20) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23GBP400; 21) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23EBW653; 22) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23DBR887; 23) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23CBG614; 24) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBK758; 25) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBJ844; 26) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBK666; 27) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBI093; 28) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22JBH355; 29) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22HBS531; 30) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBM598; 31) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBL549; 32) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK859; 33) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK858; 34) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBL968; 35) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBC616; 36) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21KBF393; 37) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21JBO077; 38) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBV804; 39) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBB808; 40) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23EBK295; 41) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23CBT556; 42) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23BBP326; 43) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABH483; 44) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABG351; 45) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22IBE748; 46) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS173; 47) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS172; 48) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22FBD583; 49) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22DBN516; 50) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 21LBW480; 51) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21FBH003; 52) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21ABX303; 53) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22OBL581; 54) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22IMH323; 55) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22GBM603; 56) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22FBO257; 57) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22DBD515; 58) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21VBC540; 59) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA989; 60) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA988; 61) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21IBP619; 62) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23FMI799; 63) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23EME858; 64) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMF336; 65) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMB940; 66) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23CMA547; 67) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24IMH073; 68) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24HMH806; 69) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24FMG472; 70) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24EMC301; 71) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24CMC328; 72) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24AMG267; 73) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23KMH550; 74) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23IMA365; 75) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23HMF744; 76) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24DMH818; 77) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24CMC092; 78) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24BMF152; 79) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24AMB397; 80) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23FME101; 81) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23EMG643; 82) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23DMH779; 83) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMF017; 84) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMB403; 85) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25BMJ035; 86) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25AMJ535; 87) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24LMC844; 88) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24KMB678; 89) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24JMB660; 90) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24GMI703; 91) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 24CMF795; 92) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 23JMI916; 93) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22KBM385; 94) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22JBK515; 95) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22IBJ349; 96) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBQ624; 97) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBN671; 98) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22FBS293; 99) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22ABS105; 100) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24BBH054; 101) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24ABU182; 102) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ766; 103) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ737; 104) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23GBG193; 105) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23DBL133; 106) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBU775; 107) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBI326; 108) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23ABG957; 109) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24IBD132; 110) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24GBJ138; 111) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25DBO814; 112) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25BBD996; 113) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24LBR473; 114) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24KBP956; 115) CDS981858F, UDI-DI: 10889942973682(each), 40889942973683(case), Lot Number: 21ABH636; 116) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22HBP524; 117) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22GBI202; 118) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 23AMB059; 119) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22LMB455; 120) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22CME430; 121) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 25BMC093; 122) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24FMA426; 123) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24EMD974; 124) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24CMB637; 125) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24AMD955; 126) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23IMF292; 127) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23HME111; 128) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LME952; 129) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LMD470; 130) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25KMJ877; 131) CDS983036K, UDI-DI: 10193489842012(each), 40193489842013(case), Lot Number: 23KBN289; 132) CDS983042K, UDI-DI: 10193489842029(each), 40193489842020(case), Lot Number: 23KBN273; 133) CDS983049K, UDI-DI: 10193489841657(each), 40193489841658(case), Lot Number: 23JBY028; 134) CDS983049K, UDI-DI: 10193489841657(each), 40193489841658(case), Lot Number: 23JBX571; 135) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21JBY974; 136) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21JBD011; 137) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21HBK744; 138) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21DBH504; 139) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21CBT358; 140) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 20LBW136; 141) CDS983297M, UDI-DI: 10193489425857(each), 40193489425858(case), Lot Number: 21FDA407; 142) CDS983480G, UDI-DI: 10195327497842(each), 40195327497843(case), Lot Number: 24CDB716; 143) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 25BMI188; 144) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 24CMA539; 145) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 24AME511; 146) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 23IMA904; 147) CDS983838G, UDI-DI: 10193489600360(each), 40193489600361(case), Lot Number: 21ADB812; 148) CDS983840I, UDI-DI: 10193489405668(each), 40193489405669(case), Lot Number: 21FDA409; 149) CDS983863D, UDI-DI: 10889942570980(each), 40889942570981(case), Lot Number: 22KDB188; 150) CDS983863D, UDI-DI: 10889942570980(each), 40889942570981(case), Lot Number: 22JDB465; 151) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 23EBK642; 152) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 23ABM823; 153) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22LBO557; 154) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22KBS560; 155) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22HBT635; 156) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22EBV412; 157) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22ABS153; 158) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22ABP297; 159) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21JBK128; 160) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21IBA056; 161) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21DBU793; 162) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21CBF370; 163) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21CBC111; 164) CDS983903D, UDI-DI: 10198459053474(each), 40198459053475(case), Lot Number: 24HBQ596; 165) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21EBR750; 166) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21DBI790; 167) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21CBJ921; 168) CDS984156L, UDI-DI: 10193489245370(each), 40193489245371(case), Lot Number: 21DBQ627; 169) CDS984156L, UDI-DI: 10193489245370(each), 40193489245371(case), Lot Number: 21CBJ888; 170) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22KBP500; 171) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22HBP143; 172) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22GBO260; 173) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22EBJ581; 174) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22CBW600; 175) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22BBX356; 176) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21KBY807; 177) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21HBM083; 178) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21GBU901; 179) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21FBL924; 180) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21CBD679; 181) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23EBJ573; 182) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23DBD812; 183) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23CBR791; 184) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23BBS246; 185) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23ABK592; 186) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25KBK734; 187) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25IBW208; 188) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25GBG607; 189) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24KBJ956; 190) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24IBP093; 191) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24IBB732; 192) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24GBU116; 193) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24GBB449; 194) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24EBF862; 195) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24DBS099; 196) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24BBS781; 197) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24ABT691; 198) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 23JBT902; 199) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 23HBV822; 200) CDS984527I, UDI-DI: 10193489376739(each), 40193489376730(case), Lot Number: 21BDA355; 201) CDS984607G, UDI-DI: 10889942719389(each), 40889942719380(case), Lot Number: 21EBC029; 202) CDS984607G, UDI-DI: 10889942719389(each), 40889942719380(case), Lot Number: 21ABV551; 203) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23DBK552; 204) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23BBU944; 205) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23ABE701; 206) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23ABA744; 207) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22JBQ863; 208) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22JBH295; 209) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22IBP797; 210) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22IBO809; 211) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22HBJ382; 212) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22GBF580; 213) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBS549; 214) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBR470; 215) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBQ393; 216) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22CBP419; 217) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21VBC530; 218) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21LBE361; 219) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21JBM719; 220) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21IBK997; 221) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 23BBG636; 222) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 23ABF816; 223) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22OBI284; 224) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22KBB895; 225) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22GBU468; 226) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22FBK619; 227) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22BBL459; 228) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 21LBQ977; 229) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 21IBV618; 230) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 24BBB251; 231) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23LBV047; 232) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23LBI902; 233) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23KBB103; 234) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23HBH071; 235) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23FBV622; 236) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23FBE479; 237) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23BBS726; 238) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 25BBD069; 239) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24LBI139; 240) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24JBU521; 241) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24JBM801; 242) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24EBR586; 243) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24DBD819; 244) CDS985279K, UDI-DI: 10195327497460(each), 40195327497461(case), Lot Number: 24CDA763; 245) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23GBT765; 246) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23DBD828; 247) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23CBP302; 248) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23ABC226; 249) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22NBE575; 250) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22LBT331; 251) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22JBR384; 252) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22GBU431; 253) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBQ646; 254) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBM692; 255) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBB121; 256) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21LBI665; 257) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21LBH556; 258) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21GBL257; 259) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21CBM829; 260) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21ABP208; 261) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24IBU020; 262) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24GBW059; 263) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24FBN572; 264) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24DBF304; 265) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24BBO443; 266) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24ABT609; 267) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 23JBS895; 268) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 23IBA494; 269) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 25CBV211; 270) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 25BBD080; 271) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 24LBD251; 272) CDS985317F, UDI-DI: 10198459309311(each), 40198459309312(case), Lot Number: 25HBD051; 273) CDS985317F, UDI-DI: 10198459309311(each), 40198459309312(case), Lot Number: 25FBK413; 274) CDS985317G, UDI-DI: 10198459509063(each), 40198459509064(case), Lot Number: 25LBC622; 275) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 23ABE885; 276) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 22KBC308; 277) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 21CBU636; 278) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 21CBH306; 279) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25KDA137; 280) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25GDA910; 281) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25DDB938; 282) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25ADB448; 283) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24IDA344; 284) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24HDA224; 285) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24ADA064; 286) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23JDB638; 287) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23CDB828; 288) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23BDB741; 289) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23ADB631; 290) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22JDB343; 291) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22FDB552; 292) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22EDA009; 293) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21HDC208; 294) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21ADB694; 295) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21ADA639; 296) DYKM1161, UDI-DI: 10888277838529(each), 40888277838520(case), Lot Number: 23ABS895; 297) DYKM2106, UDI-DI: 10195327020736(each), 40195327020737(case), Lot Number: 22FBT157; 298) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 25CBT503; 299) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24HBH168; 300) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24GBC828; 301) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24FBB726; 302) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24BBJ839; 303) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24ABH888; 304) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22KBO875; 305) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22JBP430; 306) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22IBS840; 307) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22FBI537; 308) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22FBF302; 309) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22DBM212; 310) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22CBB535; 311) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21HBG593; 312) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21HBF503; 313) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21EBE678; 314) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21ABM611; 315) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25GBP632; 316) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25FBU008; 317) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25FBK659; 318) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25EBK537; 319) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25BBI466; 320) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25ABS680; 321) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25ABQ126; 322) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24KBQ931; 323) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24IBE136; 324) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24GBV669; 325) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24GBH578; 326) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23LBO287; 327) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23KBV904; 328) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23JBB704; 329) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23HBY495; 330) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23HBH773; 331) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23GBJ242; 332) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23FBE416; 333) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23EBL742; 334) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23DBL148; 335) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23ABK726; 336) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 22JBG015; 337) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 22JBF639; 338) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22HBQ237; 339) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22FBS797; 340) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBS811; 341) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBQ939; 342) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBQ935; 343) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBF963; 344) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22CBV519; 345) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22BBR667; 346) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22ABL303; 347) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21VBB503; 348) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21IBK151; 349) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21IBJ315; 350) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21GBO489; 351) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21GBJ360; 352) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21FBF908; 353) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21EBM705; 354) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBJ601; 355) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBF326; 356) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBB270; 357) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21BBF813; 358) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21ABL153; 359) DYKMBNDL141A, UDI-DI: 1019532724776

Quantity Affected: 117907 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