Medline Industries, LP recalls Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CD
Recalled Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 1) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 14) DYNJ0373807J, UDI-DI: 10193489942996(each), 40193489942997(case), Lot Number: 22EBC904; 15) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22JBO175; 16) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22HBV873; 17) DYNJ27434R, UDI-DI: 10195327107727(each), 40195327107728(case), Lot Number: 23EBQ683; 18) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21LBL067; 19) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21CBJ513; 20) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21ABP592; 21) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 23CMG183; 22) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22KMC218; 23) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22CBV220; 24) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23EMG111; 25) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23BMG588; 26) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 22LME145; 27) DYNJ33393M, UDI-DI: 10195327567323(each), 40195327567324(case), Lot Number: 24AMC141; 28) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24LME743; 29) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24HMH344; 30) DYNJ33393O, UDI-DI: 10198459244537(each), 40198459244538(case), Lot Number: 25CMI389; 31) DYNJ36712F, UDI-DI: 10195327148027(each), 40195327148028(case), Lot Number: 22KBH638; 32) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23HBF942; 33) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23GBF010; 34) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23FBJ953; 35) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23DBD471; 36) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23BBC494; 37) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22GBK309; 38) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22EBK097; 39) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22BBZ962; 40) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22ABL203; 41) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 21LBI132; 42) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25LBE575; 43) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25DBK709; 44) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25ABN265; 45) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24JBI039; 46) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24GBV369; 47) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24FBC228; 48) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23JBH886; 49) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23IBV025; 50) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23HBR561; 51) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23FBO439; 52) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23EBL258; 53) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23DBQ854; 54) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22HBB055; 55) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22GBG579; 56) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22ABU361; 57) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21KBQ945; 58) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21HBS940; 59) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21DBN261; 60) DYNJ47694I, UDI-DI: 10195327437046(each), 40195327437047(case), Lot Number: 24GMI287; 61) DYNJ51741B, UDI-DI: 10193489538939(each), 40193489538930(case), Lot Number: 22BBC761; 62) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23GMH701; 63) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23EMA454; 64) DYNJ59037B, UDI-DI: 10193489948196(each), 40193489948197(case), Lot Number: 22GBI562; 65) DYNJ59444G, UDI-DI: 10193489431650(each), 40193489431651(case), Lot Number: 20LMF707; 66) DYNJ61282B, UDI-DI: 10195327054663(each), 40195327054664(case), Lot Number: 24ABY154; 67) DYNJ67161, UDI-DI: 10193489396744(each), 40193489396745(case), Lot Number: 22CBY767; 68) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 23JBW724; 69) DYNJ69713B, UDI-DI: 10195327340513(each), 40195327340514(case), Lot Number: 23JBY129; 70) DYNJ69713C, UDI-DI: 10195327594633(each), 40195327594634(case), Lot Number: 24EBR875; 71) DYNJ83560, UDI-DI: 10195327280291(each), 40195327280292(case), Lot Number: 23BBB410; 72) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 23AMI329; 73) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22JMF106; 74) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMC843; 75) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMB138; 76) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22HBB969; 77) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22ABL216; 78) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBH136; 79) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBC695; 80) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV717; 81) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV715; 82) DYNJ903798G, UDI-DI: 10193489420036(each), 40193489420037(case), Lot Number: 23ABR411; 83) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23EBV901; 84) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23BBM781; 85) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK510; 86) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK509; 87) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23CBD846; 88) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23ABR402; 89) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22HBS469; 90) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22BBV448; 91) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23JBI674; 92) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23IBF567; 93) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBT696; 94) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBE358; 95) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23EBR451; 96) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBV876; 97) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBG247; 98) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 23LBF494; 99) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 25ABM341; 100) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24JBK180; 101) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBM046; 102) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBG486; 103) DYNJ910537, UDI-DI: 10198459029936(each), 40198459029937(case), Lot Number: 24GBX676; 104) DYNJT3348, UDI-DI: 10198459323751(each), 40198459323752(case), Lot Number: 25EBN202; 105) DYNJV0312G, UDI-DI: 10198459489051(each), 40198459489052(case), Lot Number: 25LME070