Catalog 402656X Lot # 15076369.  Catalog 504606X Lot # 15075717.  Catalog 504656X Lot # 15076362, 15076363, and 15076364.

Cardiovascular Devices

2

No

Nationwide.

Cordis, AVANTI+ Introducer, STERILE EO, For one use only. || Catalog 402656X Lot # 15076369. || Catalog 504606X Lot # 15075717. || Catalog 504656X Lot # 15076362, 15076363, 15076364.

The Esmark bandages were a component of the following Presource Convenience Packs/Modules: Cat #PO12AUGUT, lot 9097; Cat #PO12HNGUQ, lot 9275; Cat #PO33FAPSF, lot 634802; Cat #PO53TKDMF, lot 633697; Cat #PO56TK48S, lot 634508; Cat #POMHTKWDI, lot 635911; Cat #POOCUEENK, lot 10301516; Cat #SBA11PHSLG, lot 10863; Cat #SBA32VCPAQ, lot 637321; Cat #SBA32VEMEG, lots 638023 and 634732; Cat #SBACGAAAUC, lot 986893; Cat #SBACZEXBRB, lot 633928; Cat #SCV15ACFSF, lot 634357; Cat #SOP08EPDMC, lot 985889; Cat #SOP11APCPZ, lot 8199; Cat #SOP11ARNHT, lot 10004; Cat #SOP11ATMTI, lot 634538; Cat #SOP11BKRJG, lots 9615 and 6734; Cat #SOP11ETCHA, lot 10627; Cat #SOP11EXMML, lot 9036; Cat #SOP11EXNYL, lot 10778; Cat #SOP11FASLD, lot 634159; Cat #SOP11FMLHN, lot 10708; Cat #SOP11FTJHK, lot 10593; Cat #SOP11FTSHO, lot 10244; Cat #SOP11HASWB, lot 9609; Cat #SOP11HDNSF, lot 9062; Cat #SOP11HNFHK, lot 634172; Cat #SOP11HNLDL, lot 10467; Cat #SOP11HNMOM, lot 8839; Cat #SOP11HNMUF, lot 9767; Cat #SOP11HNNBO, lot 9632; Cat #SOP11KAJEG, lot 9707; Cat #SOP11LXRJK, lot 9918; Cat #SOP11MAVUD, lot 9703; Cat #SOP11OASLE, lot 9452; Cat #SOP11OMICF, lot 8411; Cat #SOP11PDBPB, lot 635731; Cat #SOP11UPENH, lot 9510; Cat #SOP12ARKGN, lot 8802; Cat #SOP12ARMOD, lot 9744; Cat #SOP12HDCHL, lot 637167; Cat #SOP12MOVAF, lot 9751; Cat #SOP12ORKGJ, lot 8998; Cat #SOP13AROAN, lot 8160; Cat #SOP13ARXEH, lot 9704; Cat #SOP13FABOE, lot 637206; Cat #SOP13HABOD, lot 637491; Cat #SOP13HABSF, lot 9496; Cat #SOP13HAMGA, lot 10268; Cat #SOP13HNBIN, lot 9729; Cat #SOP13HNMGB, lot 9558; Cat #SOP13KNAOI, lot 9145; Cat #SOP13KNSHG, lot 8929; Cat #SOP13LEGLC, lot 11133; Cat #SOP13UEXEG, lot 636690; Cat #SOP14EXMSQ, lot 10002; Cat #SOP15AKFSG, lot 634345; Cat #SOP18ARCCE, lot 9100; Cat #SOP18ARMLC, lots 9996 and 7752; Cat #SOP18EXGHF, lot 635818; Cat #SOP18EXSLG, lot 637282; Cat #SOP18HNMFE, lot 10588; Cat #SOP18HNSFR, lot 9309; Cat #SOP18OMWBJ, lot 9985; Cat #SOP19EXFMM, lot 986794; Cat #SOP19FPSMB, lot 985369; Cat #SOP19KAEMD, lot 986851; Cat #SOP21KNSTB, lot 8140; Cat #SOP21TKHOC, lot 10023; Cat #SOP22FTSMP, lot 635580; Cat #SOP22KAMCI, lot 9023; Cat #SOP23ACBSA, lot 9966; Cat #SOP23ACUCO, lot 8999; Cat #SOP23APUCS, lot 10003; Cat #SOP23ARMZD, lot 635735; Cat #SOP23ATGMC, lot 9317; Cat #SOP23EXDUY, lot 9119; Cat #SOP23FTGME, lot 8493; Cat #SOP23HDVAI, lot 9045; Cat #SOP23HNRCQ, lot 636310; Cat #SOP23KTSMA, lot 9455; Cat #SOP23L1DUS, lot 9724; Cat #SOP23LMUCR, lot 10086; Cat #SOP23UPPCE, lot 9456; Cat #SOP23UXHWE, lot 8795; Cat #SOP24KAPSE, lot 633735; Cat #SOP29EXCFJ, lot 635695; Cat #SOP29HDUMA, lot 635594; Cat #SOP29HNMEC, lot 634278; Cat #SOP31ACOSI, lot 987042; Cat #SOP31AHSAE, lot 633267; Cat #SOP31ATMDD, lot 986850; Cat #SOP31EXLSD, lot 636577; Cat #SOP31EXNWL, lot 986251; Cat #SOP31EXRSG, lot 986895; Cat #SOP31EXSFT, lot 986268; Cat #SOP31EXSSF, lot 986831; Cat #SOP31HDCDI, lot 635667; Cat #SOP31HNEVU, lot 986962; Cat #SOP31HNSFU, lot 986275; Cat #SOP31KAMNH, lot 986943; Cat #SOP31KAOSO, lot 985700; Cat #SOP31KPEZB, lot 986891; Cat #SOP31PDJUA, lot 986837; Cat #SOP31RADGF, lot 984976; Cat #SOP31XTDSL, lot 985606; Cat #SOP32ATFSN, lot 635190; Cat #SOP32EXFCD, lot 986432; Cat #SOP32EXPAO, lot 635212; Cat #SOP32HARMI, lot 637186; Cat #SOP32HNMNN, lot 987081; Cat #SOP32HNWBO, lot 634987; Cat #SOP32KECYF, lot 986845; Cat #SOP32PDPCB, lot 635003; Cat #SOP32TKFSN, lot 637532; Cat #SOP32TKSAF, lot 633920; Cat #SOP33EXSFE, lot 985937; Cat #SOP33HDDWH, lot 635158; Cat #SOP34ACSTH, lot 636002; Cat #SOP34ARSKA, lots 985378 and 986541; Cat #SOP34TJHCD, lot 986839; Cat #SOP35ARCRJ, lot 985010; Cat #SOP35HDSTI, lots 986853 and 987204; Cat #SOP36ARAGQ, lot 9791; Cat #SOP36HACOD, lot 10586; Cat #SOP36HAFBQ, lot 9091; Cat #SOP36HNALR, lot 10257; Cat #SOP36KASRC, lot 9930; Cat #SOP36TKFBO, lot 10663; Cat #SOP36TNCAE, lot 9112; Cat #SOP3IKPIPD, lot 633880; Cat #SOP40PDDOG, lot 9098; Cat #SOP41HAMBC, lot 635589; Cat #SOP41HANSC, lot 635498; Cat #SOP41HFSUF, lot 635157; Cat #SOP41HNHMK, lot 9518; Cat #SOP41KNSOC, lot 634860; Cat #SOP41LEMBD, lot 636245; Cat #SOP41UEHMJ, lot 634162; Cat #SOP42HPKRD, lot 637131; Cat #SOP42KNKOD, lot 632967; Cat #SOP42MNKOM, lot 634092; Cat #SOP42PHOMK, lot 635492; Cat #SOP43ELLRB, lot 636119; Cat #SOP43KSLGF, lot 634293; Cat #SOP44HNSME, lot 634202; Cat #SOP44TKFSE, lot 633395; Cat #SOP44TKFSE, lot 635134; Cat #SOP45EXMKO, lot 634771; Cat #SOP45HNOCG, lot 634160; Cat #SOP45HPMVA, lot 635373; Cat #SOP48ACKAD, lot 633536; Cat #SOP48HPFAF, lot 634125; Cat #SOP48THLAA, lot 633072; Cat #SOP4AARNWC, lot 634726; Cat #SOP4AHASI1, lot 7545; Cat #SOP51ATSSC, lot 986838; Cat #SOP51EXDVG, lot 636019; Cat #SOP51LEMOG, lot 637145; Cat #SOP51XRKKB, lot 635228; Cat #SOP52FT73C, lot 634208; Cat #SOP53ARLEK, lot 634333; Cat #SOP53ETFOL, lot 635677; Cat #SOP53EXDCC, lot 635387; Cat #SOP53KNCCE, lots 633311 and 634813; Cat #SOP53KNSLC, lot 634179; Cat #SOP53MHPRI, lot 635312;  Cat #SOP53PPFRC, lot 637803; Cat #SOP54HDTCD, lot 634122; Cat #SOP54KAPRA, lot 987014; Cat #SOP55BCOKA, lot 633825; Cat #SOP56FTFOA, lot 985222; Cat #SOP56KN19R, lot 635155; Cat #SOP56KNSAQ, lot 636191; Cat #SOP56TKDCY, lot 634930; Cat #SOP57KNWGI, lot 633763; Cat #SOP59LXCPM, lot 634192; Cat #SOP59MNCHX, lot 637045; Cat #SOP5CAPGSC, lot 635171; Cat #SOP63KNSCL, lot 634454; Cat #SOP69AKPSB, lot 634161; Cat #SOP69FPEBB, lot 635340; Cat #SOP69OLFCC, lot 635445; Cat #SOP6NHDOIC, lot 986830; Cat #SOP73EXFSC, lot 636681; Cat #SOP73LOBDA, lot 635147; Cat #SOP73LXTCK, lot 634327;  Cat #SOP73TKSJB, lot 634055; Cat #SOP7CEMBRD, lot 8822; Cat #SOP92ONSID, lot 634481; Cat #SOPBOKANFE, lot 636064; Cat #SOPCGCTAUA, lot 987152; Cat #SOPCGHNWMC, lot 985228; Cat #SOPCGKAAUA, lot 987068; Cat #SOPCGTKAUB, lot 987207; Cat #SOPHBKNBIC, lot 9719; Cat #SOPHDEXRVB, lot 636398; Cat #SOPOCACPAB, lot 9760; Cat #SOPOCBOMSA, lot 10558; Cat #SPP99HD1AA, lot 636774 and 633896; Cat #SPP99KA2AA, lot 636315; Cat #SPP99PD1AA, lot 635104; Cat #SPP99TN1AA, lot 636786; Cat #SPP99TN3AA, lot 636027; Cat #SRH32STFGA, lot 635101; Cat #SRH73ACLSB, lot 635369; Cat #SRH73EXCCA, lot 986309; Cat #SRH73EXLSB, lot 635099; Cat #SRIOR0715Z, lot 9883; Cat #SUT69FBCPO, lot 633481;

General and Plastic Surgery Devices

2

No

Nationwide distribution.

Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them. || The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures.

65652-123 and 65652-124 / 1091745

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - USA including AL, AR, AZ. CA. CO,, CT, DC, DE, FL, GA, HI, IA, ID,IL,IM,KS, KY, LA, MA, MD, ME. MI MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico - and the country of Canada.

Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient. || Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient.

Lube Jelly, 1 oz. tube, component catalog #8884430200, packaged in teh following Presource Custom Sterile Convenience Packs/Modules: Cat #MBA33BULFF, lots 13636 and lot 8859; Cat #MMA33SCLFD, lot 17666; Cat #PB45LVPHS, lot 637365; Cat #PB95GYWMH, lot 639756; Cat #PB95LSWM3, lot 16532; Cat #PB95VHWMK, lot 648972; Cat #PBCGOTCD2, lot 987883; Cat #PC42OHNK1, lot 985687; Cat #PCVACV60I, lot 16685; Cat #PCVMOHB66C, lot 991632; Cat #PGVMLPBJ3, lot 986923; Cat #PL23LICVJ, lot 643894; Cat #POVFMJAGP, lot 10304554; Cat #PPV2CYWCF, lot 10305683; Cat #PU24CCJMT, lots 12027 and 16562; Cat #PU42CCTMC, lot 641817; Cat #PU42RPHCE, lot 640532; Cat #PU60PYMME, lot 16237; Cat #PUOCUSRCL, lot 10305701; Cat #PUVMCCCHJ, lots 989215 and 991685; Cat #PUVMGMCHL, lot 990250; Cat #PUVMPYBJZ, lot 989986; Cat #PV35OTSTA, lot 987931; Cat #PV35OTSTB, lots 992803 and 993264; Cat #SBA11CSMMB, lot 13601; Cat #SBA11CYHHC, lot 8474; Cat #SBA11CYOHG, lots 10651 and 16902; Cat #SBA11CYRHH, lot 14693; Cat #SBA11CYSBM, lot 10653; Cat #SBA11LESLB, lots 12037 and 16998; Cat #SBA11TUPDA, lot 11855; Cat #SBA12CYGTV, lot 636910; Cat #SBA12CYNMD, lot 16179; Cat #SBA12CYYHJ, lot 13614; Cat #SBA12MCROO, lot 10654; Cat #SBA13CCCOH, lot 17013; Cat #SBA13CTAMA, lot 14088; Cat #SBA13CYBSN, lot 14578; Cat #SBA13CYDHG, lot 18714; Cat #SBA13CYMEC, lot 15279; Cat #SBA13CYRWG, lot 15251; Cat #SBA14CYMSM, lot 635654; Cat #SBA18COFHD, lot 15253; Cat #SBA18PRSFM, lot 15424; Cat #SBA22CYBAL, lot 13619; Cat #SBA23BOUCF, lots 13954 and 17184; Cat #SBA23CPWMC, lot 13960; Cat #SBA23CTMRE, lot 637026; Cat #SBA23CYDH1, lot 13970; Cat #SBA23CYDH2, lot 17196; Cat #SBA23CYNCF, lot 13977; Cat #SBA23ENPAF, lot 12584; Cat #SBA23RPVDB, lot 16676; Cat #SBA23RUDUG, lot 14426; Cat #SBA24CYNOA, lot 13822; Cat #SBA26CYSUH, lot 13983; Cat #SBA29TRSHE, lot 991913; Cat #SBA31CYMDD, lot 989212; Cat #SBA33CYDWI, lot 636144; Cat #SBA33CYVAA, lot 992691; Cat #SBA35CYBHH, lots 988344 and 991920; Cat #SBA35CYSTF, lots 987967 and 992681; Cat #SBA35GPBPD, lots 989696 and 991674; Cat #SBA35GUMOI, lots 988577 and 991956; Cat #SBA35MUSFF, lot 993256; Cat #SBA35STBLH, lot 988354; Cat #SBA35TPPHG, lots 988560 and 989317; Cat #SBA35TRVSA, lots 990857 and 986052; Cat #SBA35URBLK, lot 989223; Cat #SBA36CYAGI, lot 640323; Cat #SBA36CYRHB, lot 636791; Cat #SBA3DCPMME, lot 16681; Cat #SBA41CYWRC, lot 642143; Cat #SBA42CSVCJ, lot 641799; Cat #SBA45CYVHG, lot 987963; Cat #SBA48CYMHF, lot 990038; Cat #SBA53CYPHC, lot 651069; Cat #SBA69CYFSF, lot 643156; Cat #SBA7ACTPNB, lot 12331; Cat #SBAHDCYRVB, lot 13817; Cat #SBAHDRBRVC, lot 14289; Cat #SBAHDTUMJD, lot 13180; Cat #SBAHFTUMDA, lot 12040; Cat #SBAOCCYWHD, lot 14587; Cat #SID11SPSBC, lot 13358; Cat #SLC23RPUCI, lot 15379; Cat #SLC69VLWSB, lot 988883; Cat #SLC81RPBGD, lot 642484; Cat #SMA11CYPCF, lot 14046; Cat #SMA11DCNYO, lot 15311; Cat #SMA11LASBL, lot 12994; Cat #SMA11VGMME, lots 12032 and 16808; Cat #SMA12CPMWP, lot 642441; Cat #SMA12CYAIF, lots 17199 and 8791; Cat #SMA12HSROM, lot 8792; Cat #SMA12TIKGH, lot 15315; Cat #SMA12VHROI, lot 641006; Cat #SMA13BCNAE, lot 17560; Cat #SMA13DCWOE, lots 12816 and 17237; Cat #SMA14VGOGI, lot 640749; Cat #SMA18CASFE, lot 643785; Cat #SMA23DCALB, lot 11728; Cat #SMA23LVMRK, lot 15653; Cat #SMA23TUMRK, lot 16940; Cat #SMA23VAMRR, lot 634328; Cat #SMA40DCBYA, lot 10383; Cat #SMA81HYNME, lot 641022; Cat #SOT41CPHNE, lot 16371; Cat #SOT48RPSEA, lot 643755; Cat #SRHHFGMMMB, lot 12734; Cat #SRHHFGMMMC, lot 18570; Cat #SRHHFNYMMD, lot 17275; Cat #SRHHFOCMMB, lot 12683; Cat #SRHHFTBMMC, lot 12719; Cat #SRICY0567H, lot 640058; Cat #SRICY0695M, lot 10436; Cat #SRICY0736T, lot 14801; Cat #SRIGS1342L, lots 11012, 14264 and 18467; Cat #SUT81CPBGF, lot 641445;

General Hospital and Personal Use Devices

1

No

Nationwide Distribution

Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. || Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper.

all recent lots of the following kit catalog numbers MAR35ARBHD, MEY23BSGMB, MEY43VPASA, MEYCGVPDPC, MEYOCVTUMA, NI05-0065A, NI12-0090C, NI12-0409C, NI12-9192, OR1235789A, OR2235789A, ORT235789A, PC15CGSPH, PCVNCGB73J, PE08EADWE, PE08EADWF, PE24MN97I, PE41MJVAI, PE73EALUN, PE82EATCR, PEHDMJSUT, PEMHETBHI, PEMHNSBHI, PEOCMJOHH, PEOCOTBDW, PEVTCESWV, PG41LSVAH, PG41MAVAH, PG41MLVAF, PG41OTVAG, PG73LBDRW, PG92OTHRM, PGCGLRLUZ, PGMHFFBHK, PH41TCVAG, PN41CYVAH, PN41LMWLI, PN41SPVAH, PN81CETMH, PN81NDTML, PNCGCRMJV, PNCGCY07H, PNCGLM60E, PNCGLMJCA, PNMHACBHN, PNMHCSBHM, PNMHVPBHK, PNOCCY36D, PO13TJWOG, PO15KATRP, PO15TKFCX, PO15TKFCY, PO21AKJVA, PO21MNJVA, PO29AKLMP, PO29AKLWK, PO29ASLWH, PO29FTLMK, PO29KRLMP, PO41ANVAG, PO41ARVAE, PO41LEVAE, PO41SHVAH, PO41TJVAH, PO42HNTMF, PO42METMH, PO43TKNOR, PO45ARNCU, PO45LENCP, PO45TK50I, PO45TKNCR, PO45TKVHA, PO46TKSPP, PO46TKSPQ, PO54EXDSH, PO55AAKCK, PO55TKQMN, PO73EXDRP, PO73TKDRP, POHDEXSUP, POHDURSUO, POMHLSBHN, POMVACNMB, POOCHNMWN, POOCHNWPV, POOCHPMWK, POOCHPWPS, POOCLXWPC, POOCOTWPP, POSVARMKM, POSVLEMKJ, POSVTKJES, POSVTKMKL, POVNAAKHB, POVNHNKHC, POVZAAMBH, PQMHCTWDL, PV08CDGHO, PV08VLGHP, PV41AAVAI, PV41AVVAF, PVVNVLS73J, PWMHLFBHD, PWMHMEBHK, PZ88ADMHE, SAM45AMSVA, SAN11ELHTD, SAN11EPNSH, SAN12AGUMF, SAN13EPLCN, SAN19PMVAC, SAN23RIRCC, SAN25BIUAS, SAN25TNUAK, SAN26BSBFP, SAN31RDWSD, SAN38SPSFF, SAN41EPHCD, SAN43ADSWJ, SAN47BS79A, SAN51CCSTR, SAN53ADVAD, SAN53AGBIA, SAN54AG53I, SAN54MY73H, SAN54PIBEJ, SAN54PITSL, SAR32ATFHD, SAR32ATFHE, SAR41ARHMC, SBA14URCHR, SBA19LVUWJ, SBA21MAHOC, SBA21MSHOC, SBA23DPN10, SBA23DPNCC, SBA23FNPCE, SBA25ANUBQ, SBA25LPKCK, SBA32TYMEG, SBA34MNAAL, SBA43ETMSD, SBA48CYMHF, SBA52LNSWD, SBA53LC95D, SBA56ORIDA, SBA56ORIDB, SBA69DRCID, SBA81MLCMA, SBACGSTAHA, SBACGUMAUD, SBAHBVSHSE, SBAMHGOBHF, SBAVZDJMBA, SBAVZDJMBB, SBB12BBUMD, SBB23CTRCI, SBB94CTDVC, SCV11ASWPC, SCV15ACFSG, SCV18OH73G, SCV18VL73F, SCV31VSLUR, SCV32OHMEU, SCV35VAMOL, SCV48VSVAL, SCV92OHCHI, SEN11EAOHH, SEN11ETCKC, SEN12BSGTE, SEN12EISUA, SEN12EISUB, SEN19TYCHB, SEN21ENHOC, SEN21TAHOC, SEN22ENMCI, SEN22ENSMA, SEN23BKCME, SEN23BKCMF, SEN23T1DUV, SEN26EALUH, SEN29DILSE, SEN33EACO2, SEN36ETSVA, SEN41MNVAD, SEN59BSCHL, SEN63MGBHE, SENMHDTBHE, SENMHEEBHF, SENOCEAHAD, SER29BRMEH, SEY11CAWGB, SEY11ETMMM, SEY13BSMHG, SEY14EYMFI, SEY18EYMHB, SEY22VTBAO, SEY23CAAEA, SEY23CAAEB, SEY23CAAEC, SEY23CRAEA, SEY33EPEOE, SEY36BKMGH, SEY36VPMGB, SEY36VTMGO, SEY56CAIHA, SH1955327B, SID11INMKA, SID23ACSGA, SID23BAFRA, SID23BCFRA, SID55BDQMA, SID55DRQMA, SLC54LPYRW, SLCHFLPUCC, SMY13MYMMC, SMY23MTPBA, SMY23MYMME, SMY26MYLEF, SMY32MGFHG, SMY32MYNMD, SMY41MEHMA, SMY94MYDVB, SNE11CNWHV, SNE11CRHKJ, SNE11LMHKE, SNE11LMHKF, SNE11PMDOB, SNE13CRVAL, SNE21NPHOC, SNE31ACLUZ, SNE31CRSLJ, SNE31SHLUZ, SNE32BS24D, SNE41SPHGA, SNE43NEGUB, SNE44CRUTI, SNE44LAUTH, SNE46CRSWA, SNE48CRMHT, SNE56ACSAO, SNE56CRSAM, SNE56LLSAO, SNU23BPNCB, SNU23BSCMF, SOP11AREDH, SOP11ARJMO, SOP11FPEDA, SOP11KAMKJ, SOP11KASHI, SOP11KASHK, SOP11KAWHM, SOP11KMVUF, SOP11KNMKJ, SOP11TKJ19, SOP13ARMRV, SOP13EXMRR, SOP13FAMRI, SOP13KNMRY, SOP14ANMFQ, SOP14ARMSS, SOP14HNKHB, SOP15AKFSG, SOP15EXFSE, SOP15HSFSD, SOP15HWFSH, SOP15HWFSI, OP15TKFSE, SOP16KNDHM, SOP18ACCOH, SOP18ARCCE, SOP18ARCOM, SOP18ARSFW, SOP18BKSFG, SOP18EXCOI, SOP18FTSFK, SOP18KNSFY, SOP18UECOK, SOP18UECOL, SOP21ACDCE, SOP21ARDCD, SOP21ARPMB, SOP21ARPMC, SOP21HASCF, SOP21KNSTC, SOP21NADCE, SOP21OSHOA, SOP21TKHOC, SOP22ARBPD, SOP22HDCLD, SOP22OTBPK, SOP23A1DUZ, SOP23ARCLD, SOP23ARCML, SOP23ARDUX, SOP23ARDUY, SOP23ARMSH, SOP23ATCMB, SOP23DDDAH, SOP23EX14A, SOP23EXDUZ, SOP23FM14H, SOP23FM14I, SOP23KN14C, SOP23KN14D, SOP23KNCMP, SOP23KNNCK, SOP23KNUMN, SOP23L1DUS, SOP23MN14C, SOP23MN14D, SOP23MNCMF, SOP23OHNCA, SOP23U1DUQ, SOP25AROSX, SOP25HNHSI, SOP25KD48I, SOP29KNLWK, SOP31ACOS2, SOP31ACOSJ, SOP31FANMJ, SOP31KANMJ, SOP31KAOS1,  SOP31KAOSP, SOP32ACFCI, SOP32ACMNA, SOP32AKHEE, SOP32AKHEF, SOP32ARFLG, SOP32ARGML, SOP32ARMWE, SOP32ARPVF, SOP32ARRGI,  SOP32ARWBM, SOP32ATFSN, SOP32ATFSO.SOP32CAFCM, SOP32CAFCN, SOP32CKFCR, SOP32EXFLD, SOP32FAMNN, SOP32FARMH, SOP32HARMJ, SOP32HDFLG, SOP32HDFSM, SOP32HDFSN, SOP32HFFCU, SOP32HNMNN, SOP32KAHUD, SOP32KAMNR, SOP32KNMN1, SOP32KNMWC, SOP32LEFSO, SOP32LEFSP, SOP32MEPVG, SOP32NKMVA, SOP32RAFCM, SOP32TKFLA, SOP32TKFSO, SOP32TKFSP, SOP32TKMRJ, SOP33ACOOM, SOP33AROOL, SOP33EXOOJ, SOP33FAOOL, SOP35TKSIE, SOP35TKSTS, SOP41AHBYA, SOP41ARWLF, SOP41ORGSF, SOP42DRTMB, SOP43ACPSA, SOP43ACPSB, SOP43ARPCE, SOP43ARPSD, SOP43KSMSA, SOP43OMMPF, SOP43SACLE, SOP43TKGLA, SOP43TKPSE, SOP45ACCUD, SOP45ACROG, SOP45AMPOD, SOP45AMPOE, SOP45ARLHW, SOP45ARVHS, SOP45BSLHT, SOP45FPCMJ, SOP45JKVHN, SOP45KAROG, SOP45KAROH, SOP45KNVHT, SOP45LESMA, SOP45LHLHD, SOP45LXVHB, SOP45MNMMQ, SOP45PLROK, SOP45TJHTA, SOP45UEROF, SOP45ULVHQ, SOP48ARCCD, SOP48TKJCD, SOP51BPJOB, SOP51BPJOC, SOP51KNWBD, SOP54ARTOJ, SOP54HNBHA, SOP54TATOA, SOP55ARPMM, SOP56ACMTO, SOP56ACTOT, SOP56ARLDT, SOP56ARUSA, SOP56ARVBN, SOP56ARVVW, SOP56ATMTM, SOP56EXLDV, SOP56EXVVW, SOP56HAMWD, SOP56HNTON, SOP56HNVVT, SOP56HUMTK, SOP56KAMWE, SOP56KNTOW, SOP56LEMTD, SOP56LFSAM, SOP56LM88A,  SOP56TKMTJ, SOP56TKVBV, SOP63SJBHI, SOP69HPSKA, SOP73APSVB, SOP73ARNPC, SOP73ARQVG, SOP73DWNOA, SOP73KNSAC, SOP81APCMA, SOPCGACWMC, SOPDHARPMC, SOPDHHPPMC, SOPHBKNBCK, SOPHDAPUMA, SOPHFKACSB, SOPOCAPMSB, SOPOCARMSC, SOPOCBOMSD, SOPOCLXWP1 and SOPOCLXWPB

General and Plastic Surgery Devices

2

No

Nationwide Distribution

Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; || The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072; || b) Tubing Extension Sets and IV Sets || component C-FG711297CP, vendor pn FG711297CP; || component C-FG711093CP, vendor pn FG711093CP; || component C-FG711298CP, vendor pn FG711298CP; || component C-FG711092CP, vendor pn FG711092CP; || c) Cast Padding || component C-9046, vendor pn 9046; || component C-9044, vendor pn 9044; || component C-9043, vendor pn 9043; || component C-9062, vendor pn 9062; || d) Scalpel Holder || component C-DD1628-6, vendor pn DD1628-6; || e) Latex Tubing || component C-806-12, vendor pn 806-12; || component C-808R, vendor pn 808R; || component C-606R, vendor pn 606R; || component C-122BA10, vendor pn 122BA10; || component C-122BA12, vendor pn 122BA12; || component C-122BA07, vendor pn 122BA07; || component C-102BA12, vendor pn 102BA12; || component C-099BA10, vendor pn 099BA10; || component C-102BA10, vendor pn 102BA10; || component C-103BA10, vendor pn 103BA10; || component C-124BA10, vendor pn 124BA10; || component C-140BA10, vendor pn 140BA10; || f) Clinic Dropper || component C-12548, vendor pn 10-871-00; || g) Tongue Blade (depressor) || component C-11820-010, vendor pn 07-920-00; || h) Catheter Clamp || component C-043-0497, vendor pn 033403-887; || i) Gillette Good News Razor || component C-P4417A, vendor pn 4417GN; || j) Prepsicle Round Short Blue Swabstick || component C-051-0401, vendor pn SBR20035; || k) Tubing || component C-SFM3-3050, vendor pn SFM3-3050; || component C-SFM3-3650, vendor pn SFM3-3650; || l) Specimen Container || component C-B9021YN, vendor pn B9021YN; || component C-C8846-18, vendor pn 15706-806; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

all recent lot numbers of the following kit catalog numbers 03-0271, 03-0692A, 03-4563C, 05-0102, 09-5197F, 12-0088, 12-5210U, 12-5596, 13-0426E, 13-0879, 13-1527B, 17-2701B, 23626-640, 23626-660, 24012-060, 24012-360, 5C4150A, CFISP3EDTA, CFISPDHCBA, CS9044 and CS9046

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072; || b) Tubing Extension Sets and IV Sets || component C-FG711297CP, vendor pn FG711297CP; || component C-FG711093CP, vendor pn FG711093CP; || component C-FG711298CP, vendor pn FG711298CP; || component C-FG711092CP, vendor pn FG711092CP; || c) Cast Padding || component C-9046, vendor pn 9046; || component C-9044, vendor pn 9044; || component C-9043, vendor pn 9043; || component C-9062, vendor pn 9062; || d) Scalpel Holder || component C-DD1628-6, vendor pn DD1628-6; || e) Latex Tubing || component C-806-12, vendor pn 806-12; || component C-808R, vendor pn 808R; || component C-606R, vendor pn 606R; || component C-122BA10, vendor pn 122BA10; || component C-122BA12, vendor pn 122BA12; || component C-122BA07, vendor pn 122BA07; || component C-102BA12, vendor pn 102BA12; || component C-099BA10, vendor pn 099BA10; || component C-102BA10, vendor pn 102BA10; || component C-103BA10, vendor pn 103BA10; || component C-124BA10, vendor pn 124BA10; || component C-140BA10, vendor pn 140BA10; || f) Clinic Dropper || component C-12548, vendor pn 10-871-00; || g) Tongue Blade (depressor) || component C-11820-010, vendor pn 07-920-00; || h) Catheter Clamp || component C-043-0497, vendor pn 033403-887; || i) Gillette Good News Razor || component C-P4417A, vendor pn 4417GN; || j) Prepsicle Round Short Blue Swabstick || component C-051-0401, vendor pn SBR20035; || k) Tubing || component C-SFM3-3050, vendor pn SFM3-3050; || component C-SFM3-3650, vendor pn SFM3-3650; || l) Specimen Container || component C-B9021YN, vendor pn B9021YN; || component C-C8846-18, vendor pn 15706-806; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

Model EX500: Lot #'s: 15410906, 15411659, 15424968, 15429098, 15429879, 15437509, 15437958, 15444208, 15449422, 15453540, 15456567, 15456568, 15462779, 15462780, 15469984, 15479199, 15481341, 15485491, 15489970, 15501955, 15505186, 15578709, 15589368, 15586530, 15602199, 15603369, 15608590, 15610801, 15617548, 15630141, 15630171, 15639388, 15642692, 15648662, 15650923, 15656441, 15664083, 15670351, 15670768.  Model EX600: Lot #'s: 15408606, 15409332, 15410622, 15410623, 15426890, 15430798, 15433095, 15433098, 15441594, 15443327, 15446063, 15448005, 15451542, 15452987, 15455770, 15455771, 15459366, 15459367, 15461179, 15461781, 15463296, 15463297, 15464298, 15464299, 15466362, 15472044, 15475128, 15475795, 15479644, 15484135, 15487458, 15491737, 15496311, 15497038, 15500078, 15500709, 15503015, 15504223, 15504224, 15504748, 15506926, 15508012, 15508353, 15508856, 15510541, 15512713, 15518232, 15540529, 15545067, 15548555, 15549324, 15550196, 15550197, 15557284, 15561545, 15561546, 15566744, 15572185, 15573480, 15579468, 15585121, 15587184, 15596793, 15601234, 15601753, 15604477, 15605089, 15609335, 15613282, 15617549, 15625033, 15627316, 15635233, 15637262, 15643624, 15644116, 15644789, 15644790, 15649759, 15663330.  Model EX700 Lot #'s: 15466361, 15471271, 15471272, 15476317, 15476743, 15482155, 15483371, 15486224, 15490397, 15535011, 15540530.

Cardiovascular Devices

3

No

US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.

Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.

Product Model ACX101, Manufacturer UDI *+ M465ACX10106*  Lot No: F1614503

Cardiovascular Devices

2

No

US distribution to FL and NJ

The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.

Recalled ventilators were manufactured prior to September 2003. Models LTV 1000, 950, 900, and 900 Model contain serial numbers less than A006500, C07000, B03500, and D01400, respectively.

Anesthesiology Devices

2

No

Nationwide and worldwide

The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.

11/25/2008 Final List of UPDATED serial numbers: 20020100 through 20030339 (format used until the end of 2003 was yyyynnnn) and range AT040350 through AT070351 (format beginning with 2004 is ATyynnnn):   Only those units that have both 2.6 software and Auditory Evoked Potential (AEP) or Cortical Auditory Evoked Potential (CAEP) functionality were affected by the split screen issue.   S/N System (version 2.6 software)   AT040554 AT40565 AT040558 AT040560 AT040559 AT040566 AT040564 AT040570 AT040571 AT040591 AT040594 AT040596 AT040596 AT050606 AT050619 AT040599 AT050622 AT050625 AT050634 AT050639 AT050640 AT050651 AT050654 AT050655 AT050652 AT050653 AT050657 AT050663 AT050674 AT050673 AT050675 AT050682 AT050680 AT050683 AT050708 AT050692 AT050690 AT050706 AT050707 AT050710 AT050732 AT050691 AT050752 AT050755 AT050743/AT050748 AT050765 AT050778 AT050776 AT050782 AT050784 AT050795 AT050801 AT050797 AT050799 AT050786 AT050805 AT050809 AT050812 AT050806 AT050816 AT050819 AT050818 AT050820 AT050829 AT050834 AT050836 AT050836 AT050842 AT050852 AT050843 AT050855 AT050853 AT060859 AT060892 AT060862 AT060864 AT060868 AT060882 AT060885 AT060886 AT060883 AT060891 AT060894 AT060884 AT060903 AT060904 AT050691P AT060914 AT060911 AT060912 AT060913 AT060892 AT060925 AT060937 AT060926 AT060940 AT060941 AT060942 AT060938 AT060944 AT060945 AT060946 AT060949 AT070205 AT070206 AT070207 AT060938 AT070219 AT070218 AT070226 AT070227 AT070228 AT070230 AT070241 AT070200 AT070253 AF071624 AT070252 AT070257 AT070221 AT070220 AT070269 AT070272 AT070273 AT070274 AT070278 AT070280 AT070290 AT070292 AT070289 AT070299 AT070304 AT070310 AT070307 AT070314 AT070317 AT070333 AT070306 AT070331 AT070339 AT070340 AT070341 AT070350 AT070370 AT070352 AT070257 AT070369 AT070376 AT070360 AT070396 AT080399 20030241 20030338 AT080417 AT070339 AT070318 AT080418 AT080426 and AT080427.  Additional serial numbers to be supplied later.

Ear, Nose, and Throat Devices

2

No

Nationwide including states of AL AZ CA CO CT DC FL GA HI IA IA IL IN KS LA MA MD ME MN MO MS NC NC NH NJ NM NY OH OK PA RI SC TN TX UT VA WA and WI.

GSI Audera (version 2.6 software) Viasys Healthcare, Inc. || Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. || The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults.

Catalog Number: 403545S, Lot Numbers: U0000027, U0000041 and U0000047;  Catalog Number: 403585S, Lot Number U0000025;  Catalog Number: 403645S, Lot Numbers U0000026, U0000030, U0000031, U0000038 and U0000052;  Catalog Number: 403685S, Lot Numbers U0000033, U0000042 and U0000050;  Catalog Number: 403745S, Lot Numbers U0000034, U0000035, U0000040, U0000043 and U0000055; and  Catalog Number: 403785S, Lot Numbers U0000037 and U0000046.

Cardiovascular Devices

2

No

Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.

Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. || Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA || Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. || The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.

Cordis POWERFLEX® PRO PTA Dilatation Catheter

Cordis AVANTI®+ Transradial Kit; Cordis Obturator

NEX510, NEX512, NEX610, NEX612, NEX710, NEX712, NEX56A, NEX66A, NEX76A

Alaris® GP volumetric pump and Alaris® GP Guardrails® volumetric pump

Cypher Select+ Sirolimuseluting Coronary Stent

Cordis SMART Control Nitionl System

S.M.A.R.T.® & S.M.A.R.T.® Control®

ExoSeal™ Vascular Closure Device (VCD)

SUPER TORQUE® MB Angiographic Catheter

Cardiovascular Devices