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Parker Quality & Compliance

PQC Reg Watch

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Device recall

Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010159C; 6) PEDS EMERGENCY TRAY-YELLOW, Catalog Number: ACC010160C; 7) PEDS EMERGENCY TRAY-WHITE, Catalog Number: ACC010161C; 8) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010162C; 9) PEDS EMERGENCY TRAY-RED, Catalog Number: ACC010163C; 10) CVHP DRAWER -IV, Catalog Number: ACC010308A; 11) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010316A; 12) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010318A; 13) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010319A; 14) DRAWER THREE - IV SET UP, Catalog Number: ACC010361; 15) DRAWER 1, Catalog Number: ACC010374A; 16) DRAWER 3 LAB DRAW & IV START, Catalog Number: ACC010417A; 17) DRAWER #6, Catalog Number: ACC010477B; 18) DRAWER #4, Catalog Number: ACC010479A; 19) ADULT DRAWER 4, Catalog Number: ACC010679; 20) DRAWER 2, Catalog Number: ACC010690; 21) DRAWER 2, Catalog Number: ACC010726; 22) DRAWER 2, Catalog Number: ACC010726A; 23) RRMC CODE CART DRAWER 3, Catalog Number: ACC010770; 24) DRAWER 2, Catalog Number: ACC010875; 25) BOTTOM DRAWER, Catalog Number: ACC010972; 26) CODE CART DRAWER TWO IV SUPPLI, Catalog Number: ACC010977; 27) DRAWER 4 CIRCULATION, Catalog Number: ACC011088; 28) NON-SUTURED SHEATH #113197 KIT, Catalog Number: DYKM1495; 29) SUTURED SHEATH W/SCI #113198, Catalog Number: DYKM1496; 30) LABOR TRIAGE KIT - LF #13232, Catalog Number: DYKM1564; 31) FINGER THORACOSTOMY PCC KIT, Catalog Number: DYKM2676A; 32) UVC KIT, Catalog Number: DYKM2677A; 33) CRIC KIT, Catalog Number: DYKM2678A; 34) SCOPE KIT 3, Catalog Number: DYKM2750; 35) SURGICAL KIT, Catalog Number: DYKM2752; 36) PRE OP KIT, Catalog Number: DYKS1022B; 37) MAC KIT, Catalog Number: DYKS1089B; 38) PRE OP KIT, Catalog Number: DYKS1091A; 39) PRE OP KIT, Catalog Number: DYKS1128B; 40) PRE OP KIT, Catalog Number: DYKS1325; 41) UCLA RAPID RESPONSE KIT, Catalog Number: DYLAB1097; 42) BSSM-WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3061; 43) WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3064; 44) WHOLE BLOOD/DOUBLE RED, Catalog Number: DYNDB3078C; 45) ACCESS KIT, Catalog Number: DYNDH1159A; 46) ADLT BLOOD CULTURE COLLECT KIT, Catalog Number: DYNDH1245; 47) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1362; 48) PEDIATRIC BLOOD CULTURE KIT, Catalog Number: DYNDH1363; 49) STANFORD TIME TO POSITIVITY, Catalog Number: DYNDH1591; 50) BLOOD CULTURE PINK PERIPHERAL, Catalog Number: DYNDV1875; 51) BLOOD CULTURE BLUE PERIPHERAL, Catalog Number: DYNDV1876; 52) NICU LINE PACK, Catalog Number: DYNJ63410; 53) STUDENT PRACTICE BAG W LOGO, Catalog Number: EDUC1043; 53)

FDA recall source

Recall number
Z-3054-2026
Event id
99334
Status
Ongoing
FDA classification
Class II
Recalling firm
Medline Industries, LP
Report date
Sep 9, 2026
Posted
Aug 31, 2026
Initiated
Jun 12, 2026
Center classification date
Aug 31, 2026
Product code
LRO
Device type
General Surgery Tray
Reason
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
Root cause
Nonconforming Material/Component
Quantity
434,595 kits
Code info
1) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2023122690; 2) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024020790; 3) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024032790; 4) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024052390; 5) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024071190; 6) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024081490; 7) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024101090; 8) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024111990; 9) DYNDH1983A, UDI-DI: 10653160388920(each), 00653160388923(case), Lot Number: 2025073190; 10) ACC010157C, UDI-DI: 10195327492649(each), 40195327492640(case), Lot Number: 23JDB105; 11) ACC010158C, UDI-DI: 10195327492786(each), 40195327492787(case), Lot Number: 23JDB122; 12) ACC010159C, UDI-DI: 10195327492779(each), 40195327492770(case), Lot Number: 23JDB078; 13) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDA433; 14) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDB266; 15) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDA587; 16) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDB267; 17) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDC145; 18) ACC010162C, UDI-DI: 10195327492793(each), 40195327492794(case), Lot Number: 23JDB106; 19) ACC010163C, UDI-DI: 10195327492809(each), 40195327492800(case), Lot Number: 23JDB268; 20) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25DDA404; 21) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25EDB078; 22) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDA297; 23) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDB295; 24) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25GDA555; 25) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB461; 26) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB645; 27) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23KDC062; 28) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23LDB762; 29) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 25CDB196; 30) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24DDA506; 31) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24EDA984; 32) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24LDA823; 33) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 24EDC133; 34) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 23KDA881; 35) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA262; 36) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA507; 37) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24EDB665; 38) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 23JDB228; 39) ACC010361, UDI-DI: 10889942944989(each), 40889942944980(case), Lot Number: 24ADA597; 40) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25CDB687; 41) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25EDB273; 42) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25FDA380; 43) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24ADA326; 44) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24DDC115; 45) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24EDB585; 46) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24FDA451; 47) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24JDA313; 48) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24LDA107; 49) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDB464; 50) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDC441; 51) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23LDB221; 52) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25BDA421; 53) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25FDB683; 54) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24JDA799; 55) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24KDB853; 56) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 23JDB187; 57) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 25CDA651; 58) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 25EDB703; 59) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 25GDB405; 60) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24ADB209; 61) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24BDA093; 62) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24BDA446; 63) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24BDC015; 64) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24CDB041; 65) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24DDB732; 66) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24EDA124; 67) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 24KDA544; 68) ACC010477B, UDI-DI: 10195327131524(each), 40195327131525(case), Lot Number: 23LDA976; 69) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25DDA606; 70) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25EDB678; 71) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25FDA196; 72) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 25HDA602; 73) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24DDB117; 74) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24EDA750; 75) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24FDB890; 76) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24HDA095; 77) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 24IDA021; 78) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 23KDB046; 79) ACC010479A, UDI-DI: 10195327131517(each), 40195327131518(case), Lot Number: 23KDC470; 80) ACC010479A, UDI-DI: 23LDB379(each), 10195327131517(case), Lot Number: 40195327131518; 81) ACC010679, UDI-DI: 25ADB289(each), 10195327396268(case), Lot Number: 40195327396269; 82) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 25CDA527; 83) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 25EDC013; 84) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24ADA519; 85) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24ADC040; 86) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24JDA657; 87) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24LDB799; 88) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 23GDB618; 89) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 25GDA245; 90) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24CDB296; 91) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24DDB313; 92) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24EDA327; 93) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24GDB902; 94) ACC010690, UDI-DI: 10195327433307(each), 40195327433308(case), Lot Number: 24JDA372; 95) ACC010726, UDI-DI: 10195327486402(each), 40195327486403(case), Lot Number: 24ADA800; 96) ACC010726, UDI-DI: 10195327486402(each), 40195327486403(case), Lot Number: 24BDB414; 97) ACC010726, UDI-DI: 10195327486402(each), 40195327486403(case), Lot Number: 23JDA881; 98) ACC010726A, UDI-DI: 10198459043666(each), 40198459043667(case), Lot Number: 24GDA002; 99) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADB026; 100) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADB445; 101) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADB860; 102) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24ADC225; 103) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24BDB043; 104) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24CDA646; 105) ACC010770, UDI-DI: 10195327576998(each), 40195327576999(case), Lot Number: 24CDC111; 106) ACC010875, UDI-DI: 10198459113659(each), 40198459113650(case), Lot Number: 25DDB627; 107) ACC010875, UDI-DI: 10198459113659(each), 40198459113650(case), Lot Number: 24JDA648; 108) ACC010972, UDI-DI: 10198459303289(each), 40198459303280(case), Lot Number: 25EDA655; 109) ACC010977, UDI-DI: 10198459308642(each), 40198459308643(case), Lot Number: 25DDA901; 110) ACC011088, UDI-DI: 10198459589577(each), 40198459589578(case), Lot Number: 26BDA548; 111) DYKM1495, UDI-DI: 10889942639748(each), 40889942639749(case), Lot Number: 23KBE256; 112) DYKM1496, UDI-DI: 10889942636082(each), 40889942636083(case), Lot Number: 24DBH449; 113) DYKM1496, UDI-DI: 10889942636082(each), 40889942636083(case), Lot Number: 24JBB668; 114) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 25DBK369; 115) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 25GBH209; 116) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24LBR594; 117) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24ABG494; 118) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24CBB243; 119) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24CBD763; 120) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24DBI378; 121) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24EBR566; 122) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24GBX258; 123) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 24JBX634; 124) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 23IBF967; 125) DYKM1564, UDI-DI: 10889942754571(each), 40889942754572(case), Lot Number: 23LBI141; 126) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 25BBE461; 127) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 24CBH132; 128) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 24CBT727; 129) DYKM2676A, UDI-DI: 10195327522988(each), 40195327522989(case), Lot Number: 23LBN569; 130) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 23LBU445; 131) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 24CBP143; 132) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 24DBF109; 133) DYKM2677A, UDI-DI: 10195327522995(each), 40195327522996(case), Lot Number: 23JBP672; 134) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 25BLA823; 135) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 25DLA868; 136) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 24CLA476; 137) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 24LLA140; 138) DYKM2678A, UDI-DI: 10195327523008(each), 40195327523009(case), Lot Number: 23LLA884; 139) DYKM2750, UDI-DI: 10198459112690(each), 40198459112691(case), Lot Number: 24JBB774; 140) DYKM2752, UDI-DI: 10198459118401(each), 40198459118402(case), Lot Number: 24KBK304; 141) DYKM2752, UDI-DI: 10198459118401(each), 40198459118402(case), Lot Number: 24KBG695; 142) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 25AMF164; 143) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24AMA227; 144) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24AMA782; 145) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24AMH643; 146) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24CMD293; 147) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24DMF883; 148) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24EMJ967; 149) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24GMH029; 150) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24GMK146; 151) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24JMH465; 152) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24KMJ204; 153) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 24LME558; 154) DYKS1022B, UDI-DI: 10193489432848(each), 40193489432849(case), Lot Number: 23JMJ533; 155) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 25CMA215; 156) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24BMB722; 157) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24DMA601; 158) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24EMB032; 159) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24GMH030; 160) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24GMK147; 161) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24HMI067; 162) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 24LMD918; 163) DYKS1089B, UDI-DI: 10193489306286(each), 40193489306287(case), Lot Number: 23KMF447; 164) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 25AMG863; 165) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 25BMC075; 166) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 23LMH153; 167) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 24EMF530; 168) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 24IMC383; 169) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 24LMF652; 170) DYKS1091A, UDI-DI: 10193489574319(each), 40193489574310(case), Lot Number: 23JMG324; 171) DYKS1128B, UDI-DI: 10193489983043(each), 40193489983044(case), Lot Number: 23LBU122; 172) DYKS1128B, UDI-DI: 10193489983043(each), 40193489983044(case), Lot Number: 23LBH912; 173) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23JBP437; 174) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23KBL343; 175) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23LBH895; 176) DYKS1325, UDI-DI: 10193489983036(each), 40193489983037(case), Lot Number: 23LBP617; 177) DYLAB1097, UDI-DI: 10198459346316(each), 40198459346317(case), Lot Number: 25FLA513; 178) DYLAB1097, UDI-DI: 10198459346316(each), 40198459346317(case), Lot Number: 25GLA297; 179) DYLAB1097, UDI-DI: 10198459346316(each), 40198459346317(case), Lot Number: 25HLA636; 180) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 25CBJ821; 181) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24ABY315; 182) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24CBK867; 183) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24DBL293; 184) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24FBA828; 185) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24JBI833; 186) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24JBX194; 187) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 23KBJ574; 188) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 23KBV200; 189) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 23LBI823; 190) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 25ABB074; 191) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 25BBP541; 192) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24ABW521; 193) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24CBA610; 194) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24DBE339; 195) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24FBC085; 196) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24IBR193; 197) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 24JBQ751; 198) DYNDB3064, UDI-DI: 10889942215782(each), 40889942215783(case), Lot Number: 23KBQ427; 199) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 25ABE987; 200) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 25BBI439; 201) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 25CBN467; 202) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24KBJ660; 203) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24LBE165; 204) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24ABE056; 205) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24ABG510; 206) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24CBG613; 207) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24CBT164; 208) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24EBR367; 209) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24FBJ717; 210) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24HBG037; 211) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 24JBB679; 212) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 23IBS706; 213) DYNDB3078C, UDI-DI: 10193489273328(each), 40193489273329(case), Lot Number: 23JBP441; 214) DYNDH1159A, UDI-DI: 10889942881659(each), 40889942881650(case), Lot Number: 24BBR188; 215) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25KME694; 216) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25AMD339; 217) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25AMI448; 218) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25BMB198; 219) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25BMD503; 220) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 25BMH151; 221) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23LMH919; 222) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24AMF220; 223) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24AMJ457; 224) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24BMB874; 225) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24BMI381; 226) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMC934; 227) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMG933; 228) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMK091; 229) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24DMF489; 230) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24EMA066; 231) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24EMH953; 232) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMB441; 233) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMF372; 234) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMG553; 235) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24GMI902; 236) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24IMD769; 237) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24JMI883; 238) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23JMC106; 239) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23JME609; 240) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23JMJ056; 241) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23KMA305; 242) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 23KMJ911; 243) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24CMK091Z; 244) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 25ABC490; 245) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 25ABT234; 246) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 25BBB152; 247) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24LBD414; 248) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24LBN281; 249) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24ABI528; 250) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24ABS533; 251) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24BBJ514; 252) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24CBA543; 253) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24CBK879; 254) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24CBQ864; 255) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24DBE149; 256) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24DBR058; 257) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24FBD953; 258) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24GBO300; 259) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24IBL629; 260) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24JBE586; 261) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24JBQ159; 262) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24KBE076; 263) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 23JBW105; 264) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 23LBE015; 265) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 25DBH954; 266) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 25GBD824; 267) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 23LBQ779; 268) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24ABY394; 269) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24CBF326; 270) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24DBL545; 271) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24EBI891; 272) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 24FBN485; 273) DYNDH1363, UDI-DI: 10888277795464(each), 40888277795465(case), Lot Number: 23KBA941; 274) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 23LMH149; 275) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24BMF431; 276) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24GMF832; 277) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24IME659; 278) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24IMI021; 279) DYNDH1591, UDI-DI: 10193489497236(each), 40193489497237(case), Lot Number: 24JMA966; 280) DYNDV1875, UDI-DI: 10888277860209(each), 40888277860200(case), Lot Number: 24AME774; 281) DYNDV1876, UDI-DI: 10888277860032(each), 40888277860033(case), Lot Number: 24CMG621; 282) DYNDV1876, UDI-DI: 10888277860032(each), 40888277860033(case), Lot Number: 24CMH613; 283) DYNDV1876, UDI-DI: 10888277860032(each), 40888277860033(case), Lot Number: 24DMH848; 284) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 25CDA509; 285) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 25CDA643; 286) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 25CDB663; 287) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 24ADB665; 288) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 24IDB069; 289) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 24IDB669; 290) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 23LDA067; 291) DYNJ63410, UDI-DI: 10193489737431(each), 40193489737432(case), Lot Number: 23LDA811; 292) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24ADA018; 293) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24DDB177; 294) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24DDB234; 295) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24GDB033; 296) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24HDA202; 297) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24HDA894; 298) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 24HDB180; 299) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDA532; 300) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB267; 301) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB288; 302) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB289; 303) EDUC1043, UDI-DI: 10195327425531(each), 40195327425532(case), Lot Number: 23LDB290; 304) EDUC1043A, UDI-DI: 10198459334559(each), 40198459334550(case), Lot Number: 25ELA281
Distribution
US Nationwide distribution.
Voluntary or mandated
Voluntary: Firm initiated
Related 510(k)s
K213481
Location
Northfield, IL, United States