Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLAND

Summary

The FDA issued a Class II for Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, by Medline Industries, LP. Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded..

Details

Product Description

Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V

Lot/Code Info: 1) DYKB1038, UDI-DI: 10193489502428(each), 40193489502429(case), Lot Number: 22GBJ869; 2) DYNDA3188, UDI-DI: 10198459303579(each), 40198459303570(case), Lot Number: 25DBF256; 3) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA998; 4) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA723; 5) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBH579; 6) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBS213; 7) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21DBS220; 8) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21HBK178; 9) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21IBV194; 10) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBJ063; 11) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBM583; 12) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABG678; 13) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABZ724; 14) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22DBL342; 15) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22IBS978; 16) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22JBV884; 17) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22LBH141; 18) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE023; 19) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE024; 20) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE025; 21) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23CBP389; 22) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBB429; 23) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBQ437; 24) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23GBB278; 25) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23HBD985; 26) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23JBN242; 27) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP034; 28) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP432; 29) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABA416; 30) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24EBF244; 31) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBB647; 32) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBO960; 33) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBE249; 34) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBW947; 35) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24HBN439; 36) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24JBC123; 37) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24KBI920; 38) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24LBO860; 39) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBV362; 40) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23BBU890; 41) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABN982; 42) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 25HBM032; 43) DYNJT3719, UDI-DI: 10198459347054(each), 40198459347055(case), Lot Number: 25EBU996; 44) DYNJT5667, UDI-DI: 10198459492129(each), 40198459492120(case), Lot Number: 25HDB174; 45) DYNJWASTEKIT2, UDI-DI: 10193489548204(each), 40193489548205(case), Lot Number: 22HBK640; 46) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25DMI117; 47) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25BMC155; 48) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24FDB534; 49) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24HDC006; 50) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24IDB770; 51) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24KDA884; 52) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24LDA938; 53) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25ADB529; 54) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25BDB719; 55) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25DDB454; 56) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25HDA895; 57) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24DBD251; 58) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24EBF801; 59) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24FBD925; 60) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBY008; 61) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24HBN127; 62) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24JBT025; 63) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24KBF095; 64) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24LBK225; 65) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25BBA827; 66) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25CBF946; 67) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25DBH070; 68) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25EBK903; 69) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBC776; 70) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25GBS410; 71) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25BBB333; 72) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25CBI608; 73) DYNJ40886B, UDI-DI: 10193489768282(each), 40193489768283(case), Lot Number: 25ELA632; 74) DYNJ41553F, UDI-DI: 10198459079634(each), 40198459079635(case), Lot Number: 25EMI492; 75) DYNJ41558D, UDI-DI: 10889942811663(each), 40889942811664(case), Lot Number: 25EMC747; 76) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24HBE996; 77) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24IBD804; 78) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24JBH568; 79) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 25EBR969; 80) DYNJ48683A, UDI-DI: 10889942491377(each), 40889942491378(case), Lot Number: 24LBO769; 81) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25FMA909; 82) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25EMJ828; 83) DYNJ57785C, UDI-DI: 10195327543624(each), 40195327543625(case), Lot Number: 24BBN969; 84) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24CBB176; 85) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24DBR422; 86) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24FBO638; 87) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24HBT927; 88) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24IBP969; 89) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24JBH473; 90) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24KBG036; 91) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25CBH396; 92) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25EBE869; 93) DYNJ62683D, UDI-DI: 10195327556518(each), 40195327556519(case), Lot Number: 24ABP681; 94) DYNJ63668B, UDI-DI: 10195327550851(each), 40195327550852(case), Lot Number: 24HME110; 95) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23BMD400; 96) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23AMA569; 97) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24HBS684; 98) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBP876; 99) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBS147; 100) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24LBL583; 101) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25CBP938; 102) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25DBQ919; 103) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25FBD407; 104) DYNJ84040B, UDI-DI: 10198459254161(each), 40198459254162(case), Lot Number: 25BMG397; 105) DYNJ86600, UDI-DI: 10198459021565(each), 40198459021566(case), Lot Number: 25BBT025; 106) DYNJ89064, UDI-DI: 10198459230820(each), 40198459230821(case), Lot Number: 25ABL031; 107) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25ABS218; 108) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25BBC477; 109) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25CBC491; 110) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25DBC830; 111) DYNJ89959, UDI-DI: 10198459300912(each), 40198459300913(case), Lot Number: 25DBD397; 112) DYNJ903566D, UDI-DI: 10195327560829(each), 40195327560820(case), Lot Number: 25HBU069; 113) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21FBN722; 114) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21HBI274; 115) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21IBL093; 116) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21KBE009; 117) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21LBG338; 118) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22GBZ027; 119) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22JMB507; 120) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22KMC060; 121) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23BMF719; 122) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23CME266; 123) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMI182; 124) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23GMI509; 125) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23JME302; 126) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23KMI130; 127) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23LMH540; 128) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24BMA155; 129) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24GME966; 130) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24IMC690; 131) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24KMG557; 132) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21GBO411; 133) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMC753; 134) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 25GMD612; 135) DYNJ907013, UDI-DI: 10193489318630(each), 40193489318631(case), Lot Number: 25FLA929; 136) NAM0032, UDI-DI: 10195327694357(each), 40195327694358(case), Lot Number: 24LBG464; 137) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21DBF029; 138) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21GBV041; 139) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21IBQ150; 140) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21KBK856; 141) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21LBA326; 142) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22CBX005; 143) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22EBO968; 144) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22HBF991; 145) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22IBR901; 146) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABL896; 147) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABN264; 148) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBA069; 149) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBM493; 150) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23EBH545; 151) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23FBF982; 152) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23HBE007; 153) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23IBE867; 154) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23JBW353; 155) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24ABL399; 156) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBB750; 157) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBP944; 158) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24EBQ247; 159) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24FBB644; 160) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24HBV207; 161) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24KBI912; 162) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25CBQ305; 163) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25DBK904; 164) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22JBD604; 165) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23KBG280; 166) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25EBH405; 167) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 25EBV199; 168) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 24FBD352; 169) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBM012; 170) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBD891; 171) VASC1155, UDI-DI: 10888277760493(each), 40888277760494(case), Lot Number: 25GBN921; 172) VASC1404, UDI-DI: 10195327366568(each), 40195327366569(case), Lot Number: 23EBI565; 173) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25GBS655; 174) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25DBJ392; 175) VASC1415A, UDI-DI: 10195327678272(each), 40195327678273(case), Lot Number: 24LBH191; 176) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24GBM956; 177) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24HBN734; 178) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24JBS224; 179) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24LBL061; 180) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25BBQ097; 181) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBK254; 182) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBN756; 183) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBU919; 184) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25DBG067; 185) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24FBQ508; 186) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25EBQ528; 187) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25ABG557; 188) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25BBE970; 189) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25CBN926; 190) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBD516; 191) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBP919

Quantity Affected: 38014 units

Reason for Recall

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-02-25

Company