Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS98509

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 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) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4B; 7) VEIN PROCEDURE KIT, Model Number:DYNDA2076C; 8) CARDIAC CATH PACK-LF, Model Number:DYNJ0150605AC; 9) CARDIAC CATH PACK-LF, Model Number:DYNJ0368386D; 10) CATH LAB PACK-LF, Model Number:DYNJ0648473Y; 11) NBMC CATH PACK-LF, Model Number:DYNJ0803367I; 12) RADIOLOGY PACK-LF, Model Number:DYNJ0928124C; 13) ANGIO PACK-LF, Model Number:DYNJ0954970I; 14) SPECIALS TRAY RADIOLOGY, Model Number:DYNJ16803D; 15) CARDIAC CATH PACK, Model Number:DYNJ19946M; 16) CATH LAB PACK, Model Number:DYNJ30955I; 17) CATH LAB PACK, Model Number:DYNJ31773K; 18) CATH PACK-LF, Model Number:DYNJ33061D; 19) DB CCL OAKWOOD PACK-LF, Model Number:DYNJ33620D; 20) CARDIAC CATH PACK MRH-LF, Model Number:DYNJ35300M; 21) CATH LAB PK, Model Number:DYNJ35643C; 22) CARDIAC CATH PACK-LF, Model Number:DYNJ39066B; 23) ANGIOGRAPHY PACK, Model Number:DYNJ42134G; 24) CATH PACK-LF, Model Number:DYNJ43101C; 25) OR ANGIO PACK-LF, Model Number:DYNJ43415D; 26) OR ANGIO PACK-LF, Model Number:DYNJ43415F; 27) ANGIOPLASTY PACK, Model Number:DYNJ44700J; 28) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ44850J; 29) RADIOLOGICAL PACK, Model Number:DYNJ44889O; 30) CARDIAC CATH PACK, Model Number:DYNJ47370B; 31) ANGIOGRAPHY PACK, Model Number:DYNJ53129D; 32) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ56772G; 33) DR. MOHINDRA PACK, Model Number:DYNJ57602G; 34) NE ENDO VASCULAR PACK, Model Number:DYNJ57940B; 35) CARDIAC CATH PACK - Q1, Model Number:DYNJ58048C; 36) OR ANGIO, Model Number:DYNJ59931B; 37) LPCH PERRY CATH PACK, Model Number:DYNJ67378C; 38) HOSPITAL REGIONAL DE CONCEPCIO, Model Number:DYNJ67918A; 39) CATH LAB PACK, Model Number:DYNJ68633; 40) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197B; 41) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197C; 42) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197D; 43) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197F; 44) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197G; 45) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197I; 46) BASIC CARDIAC CATH PACK, Model Number:DYNJ81593B; 47) CATH LAB PACK, Model Number:DYNJ83073; 48) UMC EL PASO CATH PACK, Model Number:DYNJ83089; 49) DR. MOHINDRA PACK, Model Number:DYNJ83819A; 50) VZ VAS/ANG PACK, Model Number:DYNJ83981; 51) WCPN CARDIOLOGY PACK, Model Number:DYNJ84539; 52) CATH LAB, Model Number:DYNJ85511; 53) CATH LAB, Model Number:DYNJ85511A; 54) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJT1520K; 55) CVC BUNDLE KIT, Model Number:ECVC6225A; 56) CVC 3L 7F 20CM VANTEX, Model Number:ECVC7265A; 57) ANGIOGRAPHY TRAY, Model Number:MNS9130

Lot/Code Info: 1) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24IBQ637; 2) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24KBF279; 3) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24LBF132; 4) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25CBJ807; 5) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25DBO471; 6) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25GBK506; 7) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933; 8) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 22KBQ113; 9) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23ABU376; 10) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23DBD193; 11) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23GBT819; 12) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23HBQ238; 13) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23IBR569; 14) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23KBH770; 15) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23LBO849; 16) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24ABW181; 17) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24EBM208; 18) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24GBA239; 19) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24IBE619; 20) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24JBA719; 21) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24KBJ312; 22) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24LBM892; 23) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25BBK679; 24) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25CBB540; 25) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25DBA780; 26) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25FBR530; 27) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25GBQ911; 28) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21ABI976; 29) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21BBG516; 30) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21LBJ748; 31) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093; 32) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA287; 33) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA930; 34) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21KLA100; 35) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 22ALA279; 36) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 37) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 38) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 39) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 40) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 41) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 42) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23JLA979; 43) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23KLA402; 44) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24CLA777; 45) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24FLA816; 46) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ALA014; 47) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ELA738; 48) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25HLA757; 49) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24HMD928; 50) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24KMC111; 51) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24LMB205; 52) DYNJ0150605AC, UDI-DI: 10198459106422(each), 40198459106423(case), Lot Number: 24IMB736; 53) DYNJ0368386D, UDI-DI: 10889942060245(each), 40889942060246(case), Lot Number: 23BMB501; 54) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24GBT979; 55) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24HBQ060; 56) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24IBS786; 57) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24LBE715; 58) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25ABH209; 59) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25BBT175; 60) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25CBO084; 61) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25EBR586; 62) DYNJ0803367I, UDI-DI: 10195327461027(each), 40195327461028(case), Lot Number: 23IMC122; 63) DYNJ0803367I, UDI-DI: 10195327461027(each), 40195327461028(case), Lot Number: 23JMA137; 64) DYNJ0928124C, UDI-DI: 10193489484427(each), 40193489484428(case), Lot Number: 23JLB288; 65) DYNJ0954970I, UDI-DI: 10198459297571(each), 40198459297572(case), Lot Number: 25FMJ515; 66) DYNJ16803D, UDI-DI: 10195327503710(each), 40195327503711(case), Lot Number: 23JMC203; 67) DYNJ19946M, UDI-DI: 10193489907933(each), 40193489907934(case), Lot Number: 23HBO857; 68) DYNJ30955I, UDI-DI: 10195327428051(each), 40195327428052(case), Lot Number: 23GBN513; 69) DYNJ31773K, UDI-DI: 10195327245856(each), 40195327245857(case), Lot Number: 23ABB938; 70) DYNJ33061D, UDI-DI: 10193489841428(each), 40193489841429(case), Lot Number: 21CBI315; 71) DYNJ33620D, UDI-DI: 10889942677832(each), 40889942677833(case), Lot Number: 21ADA464; 72) DYNJ35300M, UDI-DI: 10195327101169(each), 40195327101160(case), Lot Number: 22JMB302; 73) DYNJ35643C, UDI-DI: 10195327111946(each), 40195327111947(case), Lot Number: 23CBI301; 74) DYNJ39066B, UDI-DI: 10193489937268(each), 40193489937269(case), Lot Number: 23HMG433; 75) DYNJ42134G, UDI-DI: 10195327644581(each), 40195327644582(case), Lot Number: 24IBS009; 76) DYNJ43101C, UDI-DI: 10888277737327(each), 40888277737328(case), Lot Number: 21ADA535; 77) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 23IBP533; 78) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24ABI910; 79) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24CBG256; 80) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24GBV382; 81) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24HBM254; 82) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24IBU874; 83) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24KBR090; 84) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24LBQ306; 85) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 25EBF775; 86) DYNJ44700J, UDI-DI: 10195327277413(each), 40195327277414(case), Lot Number: 25JDA679; 87) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 21KBO116; 88) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABI539; 89) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABK883; 90) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22CBV346; 91) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22EBP030; 92) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22FBN577; 93) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22HBM547; 94) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22IBT510; 95) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBC588; 96) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBY064; 97) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22LBG760; 98) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22OBA581; 99) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23ABR589; 100) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23BBD736; 101) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23DBI845; 102) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23EBG893; 103) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23FBF258; 104) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23GBP204; 105) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23IBB504; 106) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22AME756; 107) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22CMA383; 108) DYNJ47370B, UDI-DI: 10889942975723(each), 40889942975724(case), Lot Number: 22LBP706; 109) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22GMI134; 110) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22IMG735; 111) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22JME805; 112) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22KMC442; 113) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22LMD047; 114) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23BMC700; 115) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23CMB279; 116) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23DMF448; 117) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23EME724; 118) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23FME772; 119) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23GMI002; 120) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23HMH791; 121) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22AMD580; 122) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22BMG182; 123) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22CMH914; 124) DYNJ57602G, UDI-DI: 10195327338169(each), 40195327338160(case), Lot Number: 23BBK044; 125) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23GBE283; 126) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23GBP181; 127) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23JBB692; 128) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23JBX727; 129) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23KBB465; 130) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24ABP912; 131) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24ABS524; 132) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24ABT394; 133) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24CBC189; 134) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24CBO358; 135) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24DBF723; 136) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24EBH891; 137) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24FBH066; 138) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24GBA907; 139) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24GBQ359; 140) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24JBB314; 141) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24JBC107; 142) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24KBN562; 143) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 24LBJ716; 144) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 25BBA430; 145) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 25DBH293; 146) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 25EBL462; 147) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 25FBK782; 148) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23FMF145; 149) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 22LMA967; 150) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23AMI769; 151) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23BME160; 152) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23DMI350; 153) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23FME284; 154) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23GMF491; 155) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23IMD765; 156) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23KMH102; 157) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23LMD057; 158) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMF744; 159) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMG318; 160) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMC509; 161) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMG251; 162) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24EMH576; 163) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24GMH576; 164) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24HMF813; 165) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24JMJ426; 166) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24KMD474; 167) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25AMG240; 168) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25CMD739; 169) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25DMK093; 170) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25FMC822; 171) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25GMF770; 172) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25HMD080; 173) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25JME465; 174) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25KMD960; 175) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22BBX590; 176) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBM388; 177) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBS611; 178) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22FBU003; 179) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22HBI355; 180) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22KBH299; 181) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22LBA917; 182) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23ABL095; 183) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23CBU118; 184) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23EBN753; 185) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23GBC772; 186) DYNJ67378C, UDI-DI: 10195327697501(each), 40195327697502(case), Lot Number: 24HME465; 187) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 21LBP804; 188) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ026; 189) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ027; 190) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22OBG779; 191) DYNJ68633, UDI-DI: 10193489837667(each), 40193489837668(case), Lot Number: 21BBQ520; 192) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23FBA862; 193) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23GBC445; 194) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23GBJ036; 195) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23HBZ547; 196) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23IBT017; 197) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBF780; 198) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBR165; 199) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24ABW070; 200) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24DBF346; 201) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24EBU925; 202) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24GBA095; 203) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24HBK118; 204) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24IBL386; 205) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24JBE696; 206) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 24LBU027; 207) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25CBG703; 208) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25DBT193; 209) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25EBR556; 210) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25FBT968; 211) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25HBT944; 212) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25LBF577; 213) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25KBE898; 214) DYNJ81197I, UDI-DI: 10198459640056(each), 40198459640057(case), Lot Number: 26ABG934; 215) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23EBT723; 216) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23GBO156; 217) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23IBJ841; 218) DYNJ83073, UDI-DI: 10195327234645(each), 40195327234646(case), Lot Number: 23DMI662; 219) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 22JMI325; 220) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23BMB766; 221) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMA913; 222) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMD375; 223) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23EMF492; 224) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23FMC409; 225) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23GMD133; 226) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23IMB693; 227) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23CBS129; 228) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23EBU525; 229) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBJ743; 230) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBV261; 231) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23HBX967; 232) DYNJ83981, UDI-DI: 10195327324124(each), 40195327324125(case), Lot Number: 23CMI086; 233) DYNJ84539, UDI-DI: 10195327375706(each), 40195327375707(case), Lot Number: 23FMH066; 234) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 23JBP557; 235) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 23JBR927; 236) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24ABR587; 237) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24BBN470; 238) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24CBV309; 239) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24DBS240; 240) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24EBN545; 241) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24FBB518; 242) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24GBK818; 243) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24HBG260; 244) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24IBI836; 245) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24KBR659; 246) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24LBK715; 247) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25BBE395; 248) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25BBP468; 249) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25CBR179; 250) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25EBB233; 251) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25EBR907; 252) DYNJ85511A, UDI-DI: 10198459413735(each), 40198459413736(case), Lot Number: 25GBN456; 253) DYNJ85511A, UDI-DI: 10198459413735(each), 40198459413736(case), Lot Number: 25HBM139; 254) DYNJT1520K, UDI-DI: 10195327436261(each), 40195327436262(case), Lot Number: 23JLA175; 255) ECVC6225A, UDI-DI: 10653160333418(each), 653160333411(case), Lot Number: 2025110690; 256) ECVC7265A, UDI-DI: 10653160345145(each), 653160345148(case), Lot Number: 2023071090; 257) ECVC7265A, UDI-DI: 10653160345145(each), 653160345148(case), Lot Number: 2024021590; 258) ECVC7265A, UDI-DI: 10653160345145(each), 653160345148(case), Lot Number: 2024042390; 259) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 22GBC976; 260) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 22HBO815; 261) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 22JBU760; 262) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 22LBK966; 263) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 23ABR642; 264) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 23CBI570; 265) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 23GBG640; 266) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 23JBN131; 267) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 23LBC300; 268) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 24ABY158; 269) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 24DBC089; 270) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 24FBF351; 271) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 24FBT379; 272) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 24IBF858; 273) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 24JBW207; 274) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 25ABS583; 275) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 25DBF439; 276) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 25EBA128; 277) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 25FBI982; 278) MNS9130, UDI-DI: 10653160281214(each), 40653160281215(case), Lot Number: 25HBP222

Quantity Affected: 39341 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