Zimmer Surgical Inc: Medical Device Recall in 2018 - (Recall #: Z-0612-2018)

A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .

Class II

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

Item No. 60400040400, Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB, 4013JABC, 4013JABD, 4013JABE, 4013JABF, 4013JABG); Lot No. 62510845 (Serial Numbers: 4013JABH, 4013JABJ, 4013JABK, 4013JABL, 4013JABM, 4013JABN, 4013JABP, 4013JABQ, 4013JABR, 4013JABS, 4013JABT, 4013JABU, 4013JABW, 4013JACA, 4013JACB, 4013JACC, 4013JACD, 4013JACE, 4013JACF, 4013JACG); Lot No. 62510927 (Serial Numbers: 4013JACH, 4013JACJ, 4013JACK, 4013JACL, 4013JACM, 4013JACN, 4013JACP, 4013JACQ, 4013JACR, 4013JACS, 4013JACT, 4013JACU, 4013JACW, 4013JADA, 4013JADB, 4013JADC, 4013JADD, 4013JADE, 4013JADF, 4013JADG); Lot No. 62510928 (Serial Numbers: 4013JADH, 4013JADJ, 4013JADK, 4013JADL, 4013JADM, 4013JADN, 4013JADP, 4013JADQ, 4013JADR, 4013JADS, 4013JADT, 4013JADU, 4013JADW, 4013JAEA, 4013JAEB, 4013JAEC, 4013JAED, 4013JAEE, 4013JAEF, 4013JAEG); Lot No. 62525817 (Serial Numbers: 4013KAAA, 4013KAAB, 4013KAAC, 4013KAAD, 4013KAAE, 4013KAAF, 4013KAAG, 4013KAAH, 4013KAAJ, 4013KAAK, 4013KAAL, 4013KAAM, 4013KAAN, 4013KAAP, 4013KAAQ, 4013KAAR, 4013KAAS, 4013KAAT, 4013KAAU, 4013KAAW); Lot No. 62525841 (Serial Numbers: 4013KABA, 4013KABB, 4013KABC, 4013KABD, 4013KABE, 4013KABF, 4013KABG, 4013KABH, 4013KABJ, 4013KABK, 4013KABL, 4013KABM, 4013KABN, 4013KABP, 4013KABQ, 4013KABR, 4013KABS, 4013KABT, 4013KABU, 4013KABW); Lot No. 62616141 (Serial Numbers: 4014BAAA, 4014BAAB, 4014BAAC, 4014BAAD, 4014BAAE, 4014BAAF, 4014BAAG, 4014BAAH, 4014BAAJ, 4014BAAK, 4014BAAL, 4014BAAM, 4014BAAN, 4014BAAP, 4014BAAQ, 4014BAAR, 4014BAAS, 4014BAAT, 4014BAAU, 4014BAAW); Lot No. 62616142 (Serial Numbers: 4014BABA, 4014BABB, 4014BABC, 4014BABD, 4014BABE, 4014BABF, 4014BABG, 4014BABH, 4014BABJ, 4014BABK, 4014BABL, 4014BABM, 4014BABN, 4014BABP, 4014BABQ, 4014BABR, 4014BABS, 4014BABT, 4014BABU, 4014BABW); Lot No. 62616143 (Serial Numbers: 4014BACA, 4014BACB, 4014BACC, 4014BACD, 4014BACE, 4014BACF, 4014BACG, 4014BACH, 4014BACJ, 4014BACK, 4014BACL, 4014BACM, 4014BACN, 4014BACP, 4014BACQ, 4014BACR, 4014BACS, 4014BACT, 4014BACU, 4014BACW); Lot No. 62616145 (Serial Number: 4014BADA, 4014BADB, 4014BADC, 4014BADD, 4014BADE, 4014BADF, 4014BADG, 4014BADH, 4014BADJ, 4014BADK, 4014BADL, 4014BADM, 4014BADN, 4014BADP, 4014BADQ, 4014BADR, 4014BADS, 4014BADT, 4014BADU, 4014BADW): Lot No. 62635795 (Serial Numbers: 4014CAAA, 4014CAAB, 4014CAAC, 4014CAAD, 4014CAAE, 4014CAAF, 4014CAAG, 4014CAAH, 4014CAAJ, 4014CAAK, 4014CAAL, 4014CAAM, 4014CAAN, 4014CAAP, 4014CAAQ, 4014CAAR, 4014CAAS, 4014CAAT, 4014CAAU, 4014CAAW); Lot No. 62635796 (Serial Numbers: 4014CABA, 4014CABB, 4014CABC, 4014CABD, 4014CABE, 4014CABF, 4014CABG, 4014CABH, 4014CABJ, 4014CABK, 4014CABL, 4014CABM, 4014CABN, 4014CABP, 4014CABQ, 4014CABR, 4014CABS, 4014CABT, 4014CABU, 4014CABW); Lot No. 62635797 (Serial Numbers: 4014CACA, 4014CACB, 4014CACC, 4014CACD, 4014CACE, 4014CACF, 4014CACG, 4014CACH, 4014CACJ, 4014CACK, 4014CACL, 4014CACM, 4014CACN, 4014CACP, 4014CACQ, 4014CACR, 4014CACS, 4014CACT, 4014CACU, 4014CACW); Lot No. 62642282 (Serial Numbers: 4014CADA, 4014CADB, 4014CADC, 4014CADD, 4014CADE, 4014CADF, 4014CADG, 4014CADH, 4014CADJ, 4014CADK, 4014CADL, 4014CADM, 4014CADN, 4014CADP, 4014CADQ, 4014CADR, 4014CADS, 4014CADT,4014CADU, 4014CADW); Lot No. 62635798 (Serial Numbers: 4014CAEA, 4014CAEB, 4014CAEC, 4014CAED, 4014CAEE, 4014CAEF, 4014CAEG, 4014CAEH, 4014CAEJ, 4014CAEK, 4014CAEL, 4014CAEM, 4014CAEN, 4014CAEP, 4014CAEQ, 4014CAER, 4014CAES, 4014CAET, 4014CAEU, 4014CAEW); Lot No. 62676173 (Serial Numbers: 4014DAAA, 4014DAAB, 4014DAAC, 4014DAAD, 4014DAAE, 4014DAAF, 4014DAAG, 4014DAAH, 4014DAAJ, 4014DAAK, 4014DAAL, 4014DAAM, 4014DAAN, 4014DAAP, 4014DAAQ, 4014DAAR, 4014DAAS, 4014DAAT, 4014DAAU, 4014DAAW); Lot No. 62676174 (Serial Numbers: 4014DABA, 4014DABB, 4014DABC, 4014DABD, 4014DABE, 4014DABF, 4014DABG, 4014DABH, 4014DABJ, 4014DABK, 4014DABL, 4014DABM, 4014DABN, 4014DABP, 4014DABQ, 4014DABR, 4014DABS, 4014DABT, 4014DABU, 4014DABW); Lot No. 62686165 (Serial Numbers: 4014DACA, 4014DACB, 4014DACC, 4014DACD, 4014DACE, 4014DACF, 4014DACG, 4014DACH, 4014DACJ, 4014DACK, 4014DACL, 4014DACM, 4014DACN, 4014DACP, 4014DACQ, 4014DACR, 4014DACS, 4014DACT, 4014DACU, 4014DACW); Lot No. 62686166 (Serial No. 4014DADA, 4014DADB, 4014DADC, 4014DADD, 4014DADE, 4014DADF, 4014DADG, 4014DADH, 4014DADJ, 4014DADK, 4014DADL, 4014DADM, 4014DADN, 4014DADP, 4014DADQ, 4014DADR, 4014DADS, 4014DADT, 4014DADU, 4014DADW); Lot No. 62686167 (Serial Numbers: 4014DAEA, 4014DAEB, 4014DAEC, 4014DAED, 4014DAEE, 4014DAEF, 4014DAEG, 4014DAEH, 4014DAEJ, 4014DAEK, 4014DAEL, 4014DAEM, 4014DAEN, 4014DAEP, 4014DAEQ, 4014DAER, 4014DAES, 4014DAET, 4014DAEU, 4014DAEW); Lot No. 62689574 (Serial Numbers: 4014DAFA, 4014DAFB, 4014DAFC, 4014DAFD, 4014DAFE, 4014DAFF, 4014DAFG, 4014DAFH, 4014DAFJ, 4014DAFK, 4014DAFL, 4014DAFM, 4014DAFN, 4014DAFP, 4014DAFQ, 4014DAFR, 4014DAFS, 4014DAFT, 4014DAFU, 4014DAFW); Lot No. 62689575 (Serial Numbers: 4014DAGA, 4014DAGB, 4014DAGC, 4014DAGD, 4014DAGE, 4014DAGF, 4014DAGG, 4014DAGH, 4014DAGJ, 4014DAGK, 4014DAGL, 4014DAGM, 4014DAGN, 4014DAGP, 4014DAGQ, 4014DAGR, 4014DAGS, 4014DAGT, 4014DAGU, 4014DAGW); Lot No. 62689611 (Serial Numbers: 4014EAAA, 4014EAAB, 4014EAAC, 4014EAAD, 4014EAAE, 4014EAAF, 4014EAAG, 4014EAAH, 4014EAAJ, 4014EAAK, 4014EAAL, 4014EAAM, 4014EAAN, 4014EAAP, 4014EAAQ, 4014EAAR, 4014EAAS, 4014EAAT, 4014EAAU, 4014EAAW); Lot No. 62689602 (Serial Numbers: 4014EABA, 4014EABB, 4014EABC, 4014EABD, 4014EABE, 4014EABF, 4014EABG, 4014EABH, 4014EABJ, 4014EABK, 4014EABL, 4014EABM, 4014EABN, 4014EABP, 4014EABQ, 4014EABR, 4014EABS, 4014EABT, 4014EABU, 4014EABW); Lot No. 62689620 (Serial Numbers: 4014EACA, 4014EACB, 4014EACC, 4014EACD, 4014EACE, 4014EACF, 4014EACG, 4014EACH, 4014EACJ, 4014EACK, 4014EACL, 4014EACM, 4014EACN, 4014EACP, 4014EACQ, 4014EACR, 4014EACS, 4014EACT, 4014EACU, 4014EACW); Lot No. 62689623 (Serial Numbers: 4014EADA, 4014EADB, 4014EADC, 4014EADD, 4014EADE, 4014EADF, 4014EADG, 4014EADH, 4014EADJ, 4014EADK, 4014EADL, 4014EADM, 4014EADN, 4014EADP, 4014EADQ, 4014EADR, 4014EADS, 4014EADT, 4014EADU, 4014EADW); Lot No. 62675189 (Serial Number: 4014DAHA); Lot No. 62688979 (Serial Numbers: 4014DAHB, 4014DAHC, 4014DAHD, 4014DAHE, 4014DAHF, 4014DAHG); Lot No. 62673235 (Serial Number: 4014DAHH); Lot No. 62683264 (Serial Number: 4014DAHJ); Lot No. 62726132 (Serial Numbers: 4014FAAA, 4014FAAB, 4014FAAC, 4014FAAD, 4014FAAE, 4014FAAF, 4014FAAG, 4014FAAH, 4014FAAJ, 4014FAAK, 4014FAAL, 4014FAAM, 4014FAAN, 4014FAAP, 4014FAAQ); Lot No. 62726133 (Serial Numbers: 4014FAAR); Lot No. 62732712 (Serial Numbers: 4014FAAS, 4014FAAT, 4014FAAU, 4014FAAW); Lot No. 62732713 (Serial Numbers: 4014FABA, 4014FABB); Lot No. 62727350 (Serial Numbers: 4014FABC, 4014FABD, 4014FABE, 4014FABF); Lot No. 62728452 (Serial Numbers: 4014FABG, 4014FABH); Lot No. 62723751 (Serial Numbers: 4014FABJ, 4014FABK, 4014FABL, 4014FABM, 4014FABN, 4014FABP, 4014FABQ, 4014FABR, 4014FABS, 4014FABT, 4014FABU, 4014FABW, 4014FACA, 4014FACB, 4014FACC, 4014FACD, 4014FACE, 4014FACF, 4014FACG, 4014FACH, 4014FACJ, 4014FACK, 4014FACL, 4014FACM, 4014FACN, 4014FACP, 4014FACQ, 4014FACR, 4014FACS, 4014FACT, 4014FACU, 4014FACW, 4014FADA, 4014FADB, 4014FADC, 4014FADD, 4014FADE, 4014FADF, 4014FADG, 4014FADH); Lot No. 62723752 (Serial Numbers: 4014FADJ, 4014FADK, 4014FADL, 4014FADM, 4014FADN, 4014FADP, 4014FADQ, 4014FADR, 4014FADS, 4014FADT, 4014FADU, 4014FADW, 4014FAEA, 4014FAEB, 4014FAEC, 4014FAED, 4014FAEE, 4014FAEF, 4014FAEG, 4014FAEH); Lot No. 62745917 (Serial Numbers: 4014FAEJ, 4014FAEK); Lot No. 62745898 (Serial Numbers: 4014FAEL, 4014FAEM, 4014FAEN); Lot No. 62749571 (Serial Numbers: 4014FAEP, 4014FAEQ, 4014FAER, 4014FAES, 4014FAET); Lot No. 62741841 (Serial Numbers: 4014FAEU, 4014FAEW, 4014FAFA, 4014FAFB, 4014FAFC, 4014FAFD, 4014FAFE, 4014FAFF, 4014FAFG, 4014FAFH, 4014FAFJ, 4014FAFK, 4014FAFL, 4014FAFM, 4014FAFN, 4014FAFP, 4014FAFQ, 4014FAFR, 4014FAFS, 4014FAFT); Lot No. 62723753 (Serial Numbers: 4014FAFU, 4014FAFW, 4014FAGA, 4014FAGB, 4014FAGC, 4014FAGD, 4014FAGE, 4014FAGF, 4014FAGG, 4014FAGH, 4014FAGJ, 4014FAGK, 4014FAGL, 4014FAGM, 4014FAGN, 4014FAGP, 4014FAGQ, 4014FAGR, 4014FAGS, 4014FAGT); Lot No. 62723754 (Serial Numbers: 4014FAJW, 4014FAKA, 4014FAKB, 4014FAKC, 4014FAKD, 4014FAKE, 4014FAKF, 4014FAKG, 4014FAKH, 4014FAKJ, 4014FAKK, 4014FAKL, 4014FAKM, 4014FAKN, 4014FAKP, 4014FAKQ, 4014FAKR, 4014FAKS, 4014FAKT, 4014FAKU); Lot No. 62745156 (Serial Numbers: 4014FAGU, 4014FAGW, 4014FAHA, 4014FAHB, 4014FAHC, 4014FAHD, 4014FAHE, 4014FAHF, 4014FAHG, 4014FAHH, 4014FAHJ, 4014FAHK, 4014FAHL, 4014FAHM, 4014FAHN, 4014FAHP, 4014FAHQ, 4014FAHR, 4014FAHS, 4014FAHT); Lot No. 62745158 (Serial Numbers: 4014FAKW, 4014FALA, 4014FALB, 4014FALC, 4014FALD, 4014FALE, 4014FALF, 4014FALG, 4014FALH, 4014FALJ, 4014FALK, 4014FALL, 4014FALM, 4014FALN, 4014FALP, 4014FALQ, 4014FALR, 4014FALS, 4014FALT, 4014FALU); Lot No. 62760910 (Serial Numbers: 4014GAAA, 4014GAAB, 4014GAAC, 4014GAAD, 4014GAAE, 4014GAAF); Lot No. 62769952 (Serial Numbers: 4014GAAG, 4014GAAH); Lot No. 62769958 (Serial Numbers: 4014GAAJ, 4014GAAK); Lot No. 62775967 (Serial Numbers: 4014GAAL, 4014GAAM, 4014GAAN, 4014GAAP); Lot No. 62748382 (Serial Numbers: 4014GAAQ, 4014GAAR, 4014GAAS, 4014GAAT, 4014GAAU, 4014GAAW, 4014GABA, 4014GABB, 4014GABC, 4014GABD, 4014GABE, 4014GABF, 4014GABG, 4014GABH, 4014GABJ, 4014GABK, 4014GABL, 4014GABM, 4014GABN, 4014GABP); Lot No. 62748393 (Serial Numbers: 4014GABQ, 4014GABR, 4014GABS, 4014GABT, 4014GABU, 4014GABW, 4014GACA, 4014GACB, 4014GACC, 4014GACD, 4014GACE, 4014GACF, 4014GACG,4014GACH, 4014GACJ, 4014GACK, 4014GACL, 4014GACM, 4014GACN, 4014GACP); Lot No. 62778431 (Serial Numbers: 4014GACQ, 4014GACR, 4014GACS, 4014GACT, 4014GACU, 4014GACW); Lot No. 62748405 (Serial Numbers: 4014GADA, 4014GADB, 4014GADC, 4014GADD, 4014GADE, 4014GADF, 4014GADG, 4014GADH, 4014GADJ, 4014GADK, 4014GADL, 4014GADM, 4014GADN, 4014GADP, 4014GADQ, 4014GADR, 4014GADS, 4014GADT, 4014GADU, 4014GADW); Lot No. 62779666 (Serial Numbers: 4014GAEA, 4014GAEB, 4014GAEC, 4014GAED); Lot No. 62779665 (Serial Numbers: 4014GAEE, 4014GAEF, 4014GAEG, 4014GAEH, 4014GAEJ); Lot No. 62748415 (Serial Numbers: 4014GAEK, 4014GAEL, 4014GAEM, 4014GAEN, 4014GAEP, 4014GAEQ, 4014GAER, 4014GAES, 4014GAET, 4014GAEU, 4014GAEW, 4014GAFA, 4014GAFB, 4014GAFC, 4014GAFD, 4014GAFE, 4014GAFF, 4014GAFG, 4014GAFH, 4014GAFJ); Lot No. 62797834 (Serial Numbers: 4014HAAA, 4014HAAB, 4014HAAC, 4014HAAD, 4014HAAE); Lot No. 62786181 (Serial Numbers: 4014HAAF, 4014HAAG, 4014HAAH, 4014HAAJ, 4014HAAK, 4014HAAL, 4014HAAM, 4014HAAN, 4014HAAP, 4014HAAQ, 4014HAAR, 4014HAAS, 4014HAAT, 4010HAAU, 4014HAAW, 4014HABA, 4014HABB, 4014HABC, 4014HABD, 4014HABE); Lot No. 62786182 (Serial Numbers: 4014HABF, 4014HABG, 4014HABH, 4014HABJ, 4014HABK, 4014HABL, 4014HABM, 4014HABN, 4014HABP, 4014HABQ, 4014HABR, 4014HABS, 4014HABT, 4014HABU, 4014HABW, 4014HACA, 4014HACB, 4014HACC, 4014HACD, 4014HACE); Lot No. 62791623 (Serial Numbers: 4014HACF, 4014HACG, 4014HACH, 4014HACJ, 4014HACK, 4014HACL, 4014HACM, 4014HACN, 4014HACP, 4014HACQ, 4014HACR, 4014HACS, 4014HACT, 4014HACU, 4014HACW, 4014HADA, 4014HADB, 4014HADC, 4014HADD, 4014HADE); Lot No. 62809993 (Serial Numbers: 4014HADF, 4014HADG, 4014HADH, 4014HADJ, 4014HADK, 4014HADL, 4014HADM, 4014HADN, 4014HADP, 4014HADQ, 4014HADR, 4014HADS, 4014HADT, 4014HADU, 4014HADW, 4014HAEA, 4014HAEB, 4014HAEC, 4014HAED, 4014HAEE); Lot No. 62812519 (Serial Numbers: 4014IAAA, 4014IAAB, 4014IAAC, 4014IAAD, 4014IAAE, 4014IAAF, 4014IAAG, 4014IAAH, 4014IAAJ, 4014IAAK, 4014IAAL, 4014IAAM, 4014IAAN, 4014IAAP, 4014IAAQ, 4014IAAR, 4014IAAS, 4014IAAT, 4014IAAU, 4014IAAW); Lot No. 62812815 (Serial Numbers: 4014IABA, 4014IABB, 4014IABC, 4014IABD, 4014IABE, 4014IABF, 4014IABG, 4014IABH, 4014IABJ, 4014IABK, 4014IABL, 4014IABM, 4014IABN, 4014IABP, 4014IABQ, 4014IABR, 4014IABS, 4014IABT, 4014IABU, 4014IABW); Lot No. 62824837 (Serial Numbers: 4014IACA, 4014IACB, 4014IACC, 4014IACD); Lot No. 62826497 (Serial Numbers: 4014IACE); Lot No. 62812816 (Serial Numbers: 4014IACF, 4014IACG, 4014IACH, 4014IACJ, 4014IACK, 4014IACL, 4014IACM, 4014IACN, 4014IACP, 4014IACQ, 4014IACR, 4014IACS, 4014IACT, 4014IACU, 4014IACW, 4014IADA, 4014IADB, 4014IADC, 4014IADD, 4014IADE); Lot No. 62831377 (Serial Numbers: 4014IADF); Lot No. 62812843 (Serial Numbers: 4014IADG, 4014IADH, 4014IADJ, 4014IADK, 4014IADL, 4014IADM, 4014IADN, 4014IADP, 4014IADQ, 4014IADR, 4014IADS, 4014IADT, 4014IADU, 4014IADW, 4014IAEA, 4014IAEB, 4014IAEC, 4014IAED, 4014IAEE, 4014IAEF); Lot No. 62838045 (Serial Numbers: 4014IAEG, 4014IAEH, 4014IAEJ, 4014IAEK, 4014IAEL, 4014IAEM, 4014IAEN); Lot No. 62812844 (Serial Numbers: 4014IAEP, 4014IAEQ, 4014IAER, 4014IAES, 4014IAET, 4014IAEU, 4014IAEW, 4014IAFA, 4014IAFB, 4014IAFC, 4014IAFD, 4014IAFE, 4014IAFF, 4014IAFG, 4014IAFH, 4014IAFJ, 4014IAFK, 4014IAFL, 4014IAFM, 4014IAFN); Lot No. 62812857 (Serial Numbers: 4014IAFP, 4014IAFQ, 4014IAFR, 4014IAFS, 4014IAFT, 4014IAFU, 4014IAFW, 4014IAGA, 4014IAGB, 4014IAGC, 4014IAGD, 4014IAGE, 4014IAGF, 4014IAGG, 4014IAGH, 4014IAGJ, 4014IAGK, 4014IAGL, 4014IAGM, 4014IAGN); Lot No. 62832912 (Serial Numbers: 4014JAAA, 4014JAAB, 4014JAAC, 4014JAAD, 4014JAAE, 4014JAAF, 4014JAAG, 4014JAAH, 4014JAAJ, 4014JAAK, 4014JAAL, 4014JAAM, 4014JAAN, 4014JAAP, 4014JAAQ, 4014JAAR, 4014JAAS, 4014JAAT 4014JAAU, 4014JAAW); Lot No. 62845553 (Serial Numbers: 4014JABA, 4014JABB, 4014JABC, 4014JABD, 4014JABE, 4014JABF, 4014JABG, 4014JABH, 4014JABJ, 4014JABK, 4014JABL, 4014JABM, 4014JABN, 4014JABP, 4014JABQ, 4014JABR, 4014JABS, 4014JABT, 4014JABU, 4014JABW); Lot No. 62832932 (Serial Numbers: 4014JACA, 4014JACB, 4014JACC, 4014JACD, 4014JACE, 4014JACF, 4014JACG, 4014JACH, 4014JACJ, 4014JACK, 4014JACL, 4014JACM, 4014JACN, 4014JACP, 4014JACQ, 4014JACR, 4014JACS, 4014JACT, 4014JACU, 4014JACW); Lot No. 62852357 (Serial Numbers: 4014JADA, 4014JADB, 4014JADC, 4014JADD, 4014JADE); Lot No. 62845554 (Serial Numbers: 4014JADF, 4014JADG, 4014JADH, 4014JADJ, 4014JADK, 4014JADL, 4014JADM, 4014JADN, 4014JADP, 4014JADQ, 4014JADR, 4014JADS, 4014JADT, 4014JADU, 4014JADW, 4014JAEA, 4014JAEB, 4014JAEC, 4014JAED, 4014JAEE); Lot No. 62832930 (Serial Numbers: 4014JAEF, 4014JAEG, 4014JAEH, 4014JAEJ, 4014JAEK, 4014JAEL, 4014JAEM, 4014JAEN, 4014JAEP, 4014JAEQ, 4014JAER, 4014JAES, 4014JAET, 4014JAEU, 4014JAEW, 4014JAFA, 4014JAFB, 4014JAFC, 4014JAFD, 4014JAFE); Lot No. 62835917 (Serial Numbers: 4014JAFF, 4014JAFG, 4014JAFH, 4014JAFJ, 4014JAFK, 4014JAFL, 4014JAFM, 4014JAFN, 4014JAFP, 4014JAFQ, 4014JAFR, 4014JAFS, 4014JAFT, 4014JAFU, 4014JAFW, 4014JAGA, 4014JAGB, 4014JAGC, 4014JAGD, 4014JAGE); Lot No. 62836063 (Serial Numbers: 4014JAGF, 4014JAGG, 4014JAGH, 4014JAGJ, 4014JAGK, 4014JAGL, 4014JAGM, 4014JAGN, 4014JAGP, 4014JAGQ, 4014JAGR, 4014JAGS, 4014JAGT, 4014JAGU, 4014JAGW, 4014JAHA, 4014JAHB, 4014JAHC, 4014JAHD, 4014JAHE); Lot No. 62836101 (Serial Numbers: 4014JAHF, 4014JAHG, 4014JAHH, 4014JAHJ, 4014JAHK, 4014JAHL, 4014JAHM, 4014JAHN, 4014JAHP, 4014JAHQ, 4014JAHR, 4014JAHS, 4014JAHT, 4014JAHU, 4014JAHW, 4014JAJA, 4014JAJB, 4014JAJC, 4014JAJD, 4014JAJE); Lot No. 62860464 (Serial Numbers: 4014JAJF, 4014JAJG, 4014JAJH, 4014JAJJ, 4014JAJK, 4014JAJL, 4014JAJM, 4014JAJN, 4014JAJP, 4014JAJQ, 4014JAJR, 4014JAJS, 4014JAJT, 4014JAJU, 4014JAJW, 4014JAKA, 4014JAKB, 4014JAKC, 4014JAKD, 4014JAKE); Lot No. 62860465 (Serial Numbers: 4014JAKF, 4014JAKG, 4014JAKH, 4014JAKJ, 4014JAKK, 4014JAKL, 4014JAKM, 4014JAKN, 4014JAKP, 4014JAKQ, 4014JAKR, 4014JAKS, 4014JAKT, 4014JAKU, 4014JAKW, 4014JALA, 4014JALB, 4014JALC, 4014JALD, 4014JALE); Lot No. 62870930 (Serial Numbers: 4014KAAA, 4014KAAB, 4014KAAC, 4014KAAD, 4014KAAE, 4014KAAF, 4014KAAG, 4014KAAH, 4014KAAJ, 4014KAAK, 4014KAAL, 4014KAAM, 4014KAAN, 4014KAAP, 4014KAAQ, 4014KAAR, 4014KAAS, 4014KAAT, 4014KAAU, 4014KAAW); Lot No. 62870931 (Serial Numbers: 4014KABA, 4014KABB, 4014KABC, 4014KABD, 4014KABE, 4014KABF, 4014KABG, 4014KABH, 4014KABJ, 4014KABK, 4014KABL, 4014KABM, 4014KABN, 4014KABP, 4014KABQ, 4014KABR, 4014KABS, 4014KABT, 4014KABU, 4014KABW); Lot No. 62869995 (Serial Numbers: 4014KACA, 4014KACB, 4014KACC, 4014KACD, 4014KACE); Lot No. 62869994 (Serial Numbers: 4014KACF, 4014KACG, 4014KACH, 4014KACJ, 4014KACK) Lot No. 62876470 (Serial Numbers: 4014KACL, 4014KACM, 4014KACN, 4014KACP, 4014KACQ, 4014KACR, 4014KACS, 4014KACT, 4014KACU, 4014KACW, 4014KADA, 4014KADB,4014KADC, 4014KADD, 4014KADE ,4014KADF,4014KADG ,4014KADH,4014KADJ, 4014KADK); Lot No. 62876471 (Serial Numbers: 4014KADL, 4014KADM, 4014KADN, 4014KADP, 4014KADQ, 4014KADR, 4014KADS, 4014KADT, 4014KADU, 4014KADW, 4014KAEA, 4014KAEB, 4014KAEC, 4014KAED, 4014KAEE, 4014KAEF, 4014KAEG, 4014KAEH, 4014KAEJ, 4014KAEK); Lot No. 62877398 (Serial Numbers: 401411110001, 401411110002, 401411110003, 401411110004, 401411110005, 401411110006, 401411110007, 401411110008, 401411110009, 401411110010, 401411110011, 401411110012, 401411110013, 401411110014, 401411110015, 401411110016, 401411110017, 401411110018, 401411110019, 401411110020); Lot No. 62877405 (Serial Numbers: 401411110021, 401411110022, 401411110023, 401411110024, 401411110025, 401411110026, 401411110027, 401411110028, 401411110029, 401411110030, 401411110031, 401411110032, 401411110033, 401411110034, 401411110035, 401411110036, 401411110037, 401411110038, 401411110039, 401411110040); Lot No. 62885591 (Serial Numbers: 401411140001, 401411140002, 401411140003, 401411140004, 401411140005); Lot No. 62877414 (Serial Numbers: 401411140006, 401411140007, 401411140008, 401411140009, 401411140010, 401411140011, 401411140012, 401411140013, 401411140014, 401411140015, 401411140016, 401411140017, 401411140018, 401411140019, 401411140020, 401411140021, 401411140022, 401411140023, 401411140024, 401411140025); Lot No. 62885589 (Serial Numbers: 401411150001, 401411150002, 401411150003, 401411150004, 401411150005); Lot No. 62885588 (Serial Numbers: 401411170001, 401411170002, 401411170003, 401411170004, 401411170005); Lot No. 62877415 (Serial Numbers: 401411180001, 401411180002, 401411180003, 401411180004, 401411180005, 401411180006, 401411180007, 401411180008, 401411180009, 401411180010, 401411180011, 401411180012, 401411180013, 401411180014, 401411180015, 401411180016, 401411180017, 401411180018, 401411180019, 401411180020); Lot No. 62904095 (Serial Numbers: 401411200001, 401411200002, 401411200003, 401411200004, 401411200005, 401411200006, 401411200007, 401411200008, 401411200009, 401411200010, 401411200011, 401411200012, 401411200013, 401411200014, 401411200015, 401411200016, 401411200017, 401411200018, 401411200019, 401411200020); Lot No. 62904096 (Serial Numbers: 401411250001, 401411250002, 401411250003, 401411250004, 401411250005, 401411250006, 401411250007, 401411250008, 401411250009, 401411250010, 401411250011, 401411250012, 401411250013, 401411250014, 401411250015, 401411250016, 401411250017, 401411250018, 401411250019, 401411250020); Lot No. 62904127 (Serial Numbers: 401412020001, 401412020002, 401412020003, 401412020004, 401412020005, 401412020006, 401412020007, 401412020008, 401412020009, 401412020010, 401412020011, 401412020012, 401412020013, 401412020014, 401412020015, 401412020016, 401412020017, 401412020018, 401412020019, 401412020020); Lot No. 62878965 (Serial Numbers: 401412040001, 401412040002, 401412040003, 401412040004, 401412040005); Lot No. 62885590 (Serial Numbers: 401412050001, 401412050002, 401412050003, 401412050004, 401412050005, 401412050006, 401412050007, 401412050008, 401412050009, 401412050010); Lot No. 62894035 (Serial Numbers: 401412080001, 401412080002, 401412080003, 401412080004, 401412080005); Lot No. 62904131 (Serial Numbers: 401412090001, 401412090002, 401412090003, 401412090004, 401412090005, 401412090006, 401412090007, 401412090008, 401412090009, 401412090010, 401412090011, 401412090012, 401412090013, 401412090014, 401412090015, 401412090016, 401412090017, 401412090018, 401412090019, 401412090020); Lot No. 62905841 (Serial Numbers: 401412110001, 401412110002, 401412110003, 401412110004, 401412110005); Lot No. 62904271 (Serial Numbers: 401412120001, 401412120002, 401412120003, 401412120004, 401412120005, 401412120006, 401412120007, 401412120008, 401412120009, 401412120010, 401412120011, 401412120012, 401412120013, 401412120014, 401412120015, 401412120016, 401412120017, 401412120018, 401412120019, 401412120020); Lot No. 62905845 (Serial Numbers: 401412120021, 401412120022, 401412120023, 401412120024, 401412120025); Lot No. 62932765 (Serial Numbers: 401412160001, 401412160002, 401412160003, 401412160004, 401412160005); Lot No. 62904272 (Serial Numbers: 401412170001, 401412170002, 401412170003, 401412170004, 401412170005, 401412170006, 401412170007, 401412170008, 401412170009, 401412170010, 401412170011, 401412170012, 401412170013, 401412170014, 401412170015, 401412170016, 401412170017, 401412170018, 401412170019, 401412170020); Lot No. 62932247 (Serial Numbers: 401501020001, 401501020002, 401501020003, 401501020004, 401501020005, 401501020006, 401501020007, 401501020008, 401501020009, 401501020010, 401501020011, 401501020012, 401501020013, 401501020014, 401501020015, 401501020016, 401501020017, 401501020018, 401501020019, 401501020020); Lot No. 62932251 (Serial Numbers: 401501080001, 401501080002, 401501080003, 401501080004, 401501080005, 401501080006, 401501080007, 401501080008, 401501080009, 401501080010, 401501080011, 401501080012, 401501080013, 401501080014, 401501080015, 401501080016, 401501080017, 401501080018, 401501080019, 401501080020); Lot No. 62932249 (Serial Numbers: 401501080021, 401501080022, 401501080023, 401501080024, 401501080025, 401501080026, 401501080027, 401501080028, 401501080029, 401501080030, 401501080031, 401501080032, 401501080033, 401501080034, 401501080035, 401501080036, 401501080037, 401501080038, 401501080039, 401501080040); Lot No. 62932628 (Serial Numbers: 401501090001, 401501090002, 401501090003, 401501090004, 401501090005, 401501090006, 401501090007, 401501090008, 401501090009, 401501090010, 401501090011, 401501090012, 401501090013, 401501090014, 401501090015, 401501090016, 401501090017, 401501090018, 401501090019, 401501090020); Lot No. 62945084 (Serial Numbers: 401501090021, 401501090022, 401501090023, 401501090024, 401501090025); Lot No. 62932630 (Serial Numbers: 401501120001, 401501120002, 401501120003, 401501120004, 401501120005, 401501120006, 401501120007, 401501120008, 401501120009, 401501120010, 401501120011, 401501120012, 401501120013, 401501120014, 401501120015, 401501120016, 401501120017, 401501120018, 401501120019, 401501120020); Lot No. 62932632 (Serial Numbers: 401501130001, 401501130002, 401501130003, 401501130004, 401501130005, 401501130006, 401501130007, 401501130008, 401501130009, 401501130010, 401501130011, 401501130012, 401501130013, 401501130014, 401501130015, 401501130016, 401501130017, 401501130018, 401501130019, 401501130020); Lot No. 62932651 (Serial Numbers: 401501140001, 401501140002, 401501140003, 401501140004, 401501140005, 401501140006, 401501140007, 401501140008, 401501140009, 401501140010, 401501140011, 401501140012, 401501140013, 401501140014, 401501140015, 401501140016, 401501140017, 401501140018, 401501140019, 401501140020); Lot No. 62932652 (Serial Numbers: 401501150001, 401501150002, 401501150003, 401501150004, 401501150005, 401501150006, 401501150007, 401501150008, 401501150009, 401501150010, 401501150011, 401501150012, 401501150013, 401501150014, 401501150015, 401501150016, 401501150017, 401501150018, 401501150019, 401501150020); Lot No. 62932663 (Serial Numbers: 401501200001, 401501200002, 401501200003, 401501200004, 401501200005, 401501200006, 401501200007, 401501200008, 401501200009, 401501200010, 401501200011, 401501200012, 401501200013, 401501200014, 401501200015, 401501200016, 401501200017, 401501200018, 401501200019, 401501200020); Lot No. 62932666 (Serial Numbers: 401501210001, 401501210002, 401501210003, 401501210004, 401501210005, 401501210006, 401501210007, 401501210008, 401501210009, 401501210010, 401501210011, 401501210012, 401501210013, 401501210014, 401501210015, 401501210016, 401501210017, 401501210018, 401501210019, 401501210020); Lot No. 62962026 (Serial Numbers: 401501230001, 401501230002, 401501230003); Lot No. 62961808 (Serial Numbers: 401501260001, 401501260002, 401501260003, 401501260004, 401501260005, 401501260006, 401501260007, 401501260008, 401501260009, 401501260010, 401501260011, 401501260012, 401501260013, 401501260014, 401501260015, 401501260016, 401501260017, ,401501260018, 401501260019, 401501260020); Lot No. 62961810 (Serial Numbers: 401501290001, 401501290002, 401501290003, 401501290004, 401501290005, 401501290006, 401501290007, 401501290008, 401501290009, 401501290010, 401501290011, 401501290012, 401501290013, 401501290014, 401501290015, 401501290016, 401501290017, 401501290018, 401501290019, 401501290020); Lot No. 62945079 (Serial Numbers: 401502050001, 401502050002, 401502050003, 401502050004, 401502050005, 401502050006, 401502050007, 401502050008, 401502050009, 401502050010); Lot No. 62961812 (Serial Numbers: 401502060001, 401502060002, 401502060003, 401502060004, 401502060005, 401502060006, 401502060007, 401502060008, 401502060009, 401502060010, 401502060011, 401502060012, 401502060013, 401502060014, 401502060015, 401502060016, 401502060017, 401502060018, 401502060019, 401502060020); Lot No. 62969001 (Serial Numbers: 401502070001, 401502070002, 401502070003, 401502070004, 401502070005); Lot No. 62961815 (Serial Numbers: 401502120001, 401502120002, 401502120003, 401502120004, 401502120005, 401502120006, 401502120007, 401502120008, 401502120009, 401502120010, 401502120011, 401502120012, 401502120013, 401502120014, 401502120015, 401502120016, 401502120017, 401502120018, 401502120019, 401502120020); Lot No. 62961816 (Serial Numbers: 401502170001, 401502170002, 401502170003, 401502170004, 401502170005, 401502170006, 401502170007, 401502170008, 401502170009, 401502170010, 401502170011, 401502170012, 401502170013, 401502170014, 401502170015, 401502170016, 401502170017, 401502170018, 401502170019, 401502170020); Lot No. 62985038 (Serial Numbers: 401502180001, 401502180002, 401502180003, 401502180004, 401502180005, 401502180006, 401502180007, 401502180008, 401502180009, 401502180010); Lot No. 62961817 (Serial Numbers: 401502190001, 401502190002, 401502190003, 401502190004, 401502190005, 401502190006, 401502190007, 401502190008, 401502190009, 401502190010, 401502190011, 401502190012, 401502190013, 401502190014, 401502190015, 401502190016, 401502190017, 401502190018, 401502190019, 401502190020); Lot No. 62983026 (Serial Numbers: 401502190021, 401502190022, 401502190023, 401502190024, 401502190025); Lot No. 62961818 (Serial Numbers: 401502240001, 401502240002, 401502240003, 401502240004, 401502240005, 401502240006, 401502240007, 401502240008, 401502240009, 401502240010, 401502240011, 401502240012, 401502240013, 401502240014, 401502240015, 401502240016, 401502240017, 401502240018, 401502240019, 401502240020); Lot No. 62976482 (Serial Numbers: 401502260001, 401502260002, 401502260003, 401502260004, 401502260005, 401502260006, 401502260007, 401502260008, 401502260009, 401502260010, 401502260011, 401502260012, 401502260013, 401502260014, 401502260015, 401502260016, 401502260017, 401502260018, 401502260019, 401502260020); Lot No. 63000878 (Serial Numbers: 401503130001, 401503130002, 401503130003); Lot No. 63003147 (Serial Numbers: 401503190001, 401503190002, 401503190003, 401503190004, 401503190005); Lot No. 63003149 (Serial Numbers: 401503230001, 401503230002, 401503230003, 401503230004, 401503230005, 401503230006, 401503230007, 401503230008); Lot No. 62976483 (Serial Numbers: 401503310001, 401503310002, 401503310003, 401503310004, 401503310005, 401503310006, 401503310007, 401503310008, 401503310009, 401503310010, 401503310011, 401503310012, 401503310013, 401503310014, 401503310015, 401503310016, 401503310017, 401503310018, 401503310019, 401503310020); Lot No. 63007860 (Serial Numbers: 401504020001, 401504020002, 401504020003, 401504020004, 401504020005, 401504020006, 401504020007, 401504020008, 401504020009, 401504020010, 401504020011, 401504020012, 401504020013, 401504020014, 401504020015, 401504020016, 401504020017, 401504020018, 401504020019, 401504020020); Lot No. 63035646 (Serial Numbers: 401504060001, 401504060002, 401504060003, 401504060004, 401504060005, 401504060006, 401504060007, 401504060008); Lot No. 63035645 (Serial Numbers: 401504060009, 401504060010, 401504060011, 401504060012, 401504060013, 401504060014, 401504060015, 401504060016, 401504060017, 401504060018, 401504060019, 401504060020, 401504060021, 401504060022, 401504060023); Lot No. 63035647 (Serial Numbers: 401504090001, 401504090002, 401504090003, 401504090004, 401504090005, 401504090006, 401504090007, 401504090008, 401504090009, 401504090010); Lot No. 62976488 (Serial Numbers: 401504090011, 401504090012, 401504090013, 401504090014, 401504090015, 401504090016, 401504090017, 401504090018, 401504090019, 401504090020, 401504090021, 401504090022, 401504090023, 401504090024, 401504090025, 401504090026, 401504090027, 401504090028, 401504090029, 401504090030); Lot No. 63007861 (Serial Numbers: 401504150001, 401504150002, 401504150003, 401504150004, 401504150005, 401504150006, 401504150007, 401504150008, 401504150009, 401504150010, 401504150011, 401504150012, 401504150013, 401504150014, 401504150015, 401504150016, 401504150017, 401504150018, 401504150019, 401504150020); Lot No. 63007859 (Serial Numbers: 401504150021, 401504150022, 401504150023, 401504150024, 401504150025, 401504150026, 401504150027, 401504150028, 401504150029, 401504150030, 401504150031, 401504150032, 401504150033, 401504150034, 401504150035, 401504150036, 401504150037, 401504150038, 401504150039, 401504150040); Lot No. 63042185 (Serial Numbers: 401504200001, 401504200002, 401504200003, 401504200004, 401504200005); Lot No. 63007862 (Serial Numbers: 401504210001, 401504210002, 401504210003, 401504210004, 401504210005, 401504210006, 401504210007, 401504210008, 401504210009, 401504210010, 401504210011, 401504210012, 401504210013, 401504210014, 401504210015, 401504210016, 401504210017, 401504210018, 401504210019, 401504210020); Lot No. 63042186 (Serial Numbers: 401504210021, 401504210022, 401504210023, 401504210024, 401504210025, 401504210026, 401504210027, 401504210028, 401504210029, 401504210030, 401504210031, 401504210032, 401504210033, 401504210034, 401504210035, 401504210036, 401504210037, 401504210038, 401504210039, 401504210040); Lot No. 63007864 (Serial Numbers: 401504240001, 401504240002, 401504240003, 401504240004, 401504240005, 401504240006, 401504240007, 401504240008, 401504240009, 401504240010, 401504240011, 401504240012, 401504240013, 401504240014, 401504240015, 401504240016, 401504240017, 401504240018, 401504240019, 401504240020); Lot No. 63037265 (Serial Numbers: 401504270001, 401504270002, 401504270003, 401504270004, 401504270005, 401504270006, 401504270007, 401504270008, 401504270009, 401504270010, 401504270011, 401504270012, 401504270013, 401504270014, 401504270015, 401504270016, 401504270017, 401504270018, 401504270019, 401504270020); Lot No. 63037270 (Serial Numbers: 401504290001, 401504290002, 401504290003, 401504290004, 401504290005, 401504290006, 401504290007, 401504290008, 401504290009, 401504290010, 401504290011, 401504290012, 401504290013, 401504290014, 401504290015, 401504290016, 401504290017, 401504290018, 401504290019, 401504290020); Lot No. 63037272 (Serial Numbers: 401505010001, 401505010002, 401505010003, 401505010004, 401505010005, 401505010006, 401505010007, 401505010008, 401505010009, 401505010010, 401505010011, 401505010012, 401505010013, 401505010014, 401505010015, 401505010016, 401505010017, 401505010018, 401505010019, 401505010020); Lot No. 63037274 (Serial Numbers: 401505070001, 401505070002, 401505070003, 401505070004, 401505070005, 401505070006,

Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..

Voluntary: Firm initiated