Device Recall Innova

Serial 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Radiology Devices

2

No

Worldwide distribution: States of AL, AZ, AR, CA, CO, CT,DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV,NH, NJ, NM, NH,NC, ND, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and countries of VENEZUELA, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT , ECUADOR, COLOMBIA, CHINA, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ALGERIA.

Innova 2000, manufactured by GE Medical Systems, SCS

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.

a. Innova 5 x 200 x 130 (Batch No. 18095733, 18137885, 18233108, 18379812, 18362996, 18420576, 18404859, 18457350, 18478823, 18488703, 18519986, 18696468, 18670333, 18667082, 18756979, 18855752, 18844729, 18872178, 18886680, 18866631, 18892405, 18900294, 18951278, 19039704, 19064055, 19079251, 19111601, 19173251, 19206070, 19238815, 19231426, 19351863, 19309202, 19382422, 19367647, 19426956, 19483869, 19490837, 19501322, 19540549, 19540559, 19569664, 19641827, 19750808, 19742326, 19830060, 19844547, 19873365, 19907333, 19970577, 20014162, 20080095, 20096498, 20112175, 20186872, 20223208, 20216043, 20435880, 20151952, 20444934, 20439618, 20314154, 20336209, 20394072, 20608020, 20608137, 20607734, 20657170, 20420612, 20337854, 20450027, 20616298, 20777472, 20470018, 20672513, 20832034, 20876897, 20871401, 20728970, 20776633, 20851808, 20975844, 21020806, 21124105, 21045072, 21057925, 21091417, 21115593);  b. Innova 5 x 200 x 75 (Batch No. 18343796, 18115802, 18379813, 19013283, 21124110);  c. Innova 6 x 200 x 130 (Batch No. 18152540, 18137923, 18096697, 18119044, 18119040, 18115810, 18230863, 18108301, 18230864, 18211280, 18211281, 18245462, 18230637, 18230636, 18410450, 18428643, 18473268, 18283383, 18343799, 18439907, 18431333, 18368130, 18523235, 18519980, 18661526, 18488709, 18389662, 18498563, 18515152, 18446693, 18733063, 18759192, 18759189, 18766678, 19540741, 18791863, 18832544, 18792872, 18855754, 18860236, 18823216, 18866636, 18844738, 18892194, 18900365, 18870948, 18872541, 18878446, 18900381, 18888435, 18988348, 18961203, 19064043, 18945808, 19072771, 19111551, 19079253, 19151922, 19116475, 19164618, 19206072, 19226126, 19141574, 19245284, 19240145, 19288826, 19288832, 19309205, 19309206, 19367648, 19377502, 19408962, 19426948, 19389007, 19490838, 19511466, 19501332, 19517646, 19545788, 19555598, 19560848, 19569663, 19589370, 19584757, 19641826, 19635253, 19664685, 19654162, 19670616, 19709446, 19728413, 19699320, 19782868, 19693686, 19682956, 19682955, 19830064, 19873362, 19907334, 19905446, 19941738, 19942503, 19918783, 20013959, 19970579, 20014164, 20023939, 20109861, 20188996, 20080098, 20080097, 20188052, 20187538, 20080096, 20109863, 20112179, 20320562, 20830984, 20216045, 20183756, 20158213, 20433364, 20434473, 20233669, 20286988, 20233670, 20303729, 20342627, 20233668, 20607288, 20574727, 20607402, 20455108, 20368051, 20432603, 20511193, 20394775, 20594724, 20635843, 20776979, 20478648, 20821884, 20754076, 20758252, 20821886, 20800469, 20886809, 20825353, 20885852, 20938124, 20913156, 20950528, 20975845, 20997424, 21004412, 21119055, 21117395, 21058225, 21098042, 21071017, 21122202, 21145025, 21145024, 21219047, 21219242, 21219052);  d. Innova 6 x 200 x 75 (Batch No. 18389661, 18623249, 18870949, 18900366, 19161485, 19245285, 19918786, 20635844, 20862432, 21098043);  e. Innova 7 x 200 x 130 (Batch No. 18152541, 18099223, 18130828, 18113523, 18230638, 18217571, 18211282, 18186723, 18240225, 18168041, 18291418, 18339045, 18368242, 18283384, 18339044, 18316737, 18394605, 18385509, 18420569, 18313150, 18488713, 18921110, 18961213, 19072776, 19134318, 19173258, 19161488, 19206078, 19228862, 19255680, 19288830, 19309211, 19377507, 19327253, 19408970, 19436702, 19483875, 19491821, 19501423, 19527344, 19555961, 19545789, 19624864, 19659433, 19693528, 19670619, 19709445, 19830069, 19811429, 19742336, 19918785, 19907336, 19851529, 19974524, 19974523, 20080094, 20001802, 20109860, 20001803, 20188364, 20109862, 20177945, 20181650, 20210393, 20244728, 20321275, 20320380, 20286989, 20434033, 20267930, 20405389, 20381126, 20316570, 20574731, 20607286, 20352590, 20442151, 20466869, 20622461, 20655052, 20495971, 20518171, 20628127, 20777268, 20777261, 20820730, 20731022, 20833824, 20758256, 20886953, 20819295, 20856506, 20910181, 20937554, 21004415, 21119514, 20997428, 21119515, 21045505, 21103020, 21058247, 21138682, 21217652);  f. Innova 7 x 200 x 75 (Batch No. 18336507, 18598712, 18733075, 18802238, 18892409, 18999955, 19151414, 19245286, 19511477, 19569668, 19684652, 19811430, 20699739, 20729796, 20978808, 21122996);  g. Innova 8 x 200 x 130 (Batch No. 18211294, 18313156, 18385119, 18519981, 18583365, 18611781, 18733076, 18754584, 18780335, 18844724, 18977671, 19006855, 19048092, 19072779, 19188060, 19245289, 19304348, 19351866, 19454525, 19501424, 19624788, 19664694, 19684647, 19839023, 19782933, 20014160, 20080099, 20112342, 20216047, 20286991, 20439603, 20386608, 20655679, 20655677, 20329707, 20410534, 20655798, 20357647, 20997431, 21123358, 21123667);  h. Innova 8 x 200 x 75 (Batch No. 18115809, 18313157, 18877978, 19161490, 19624794, 19887625, 20410535, 20862411)

Cardiovascular Devices

3

Yes

Worldwide Distribution - US Nationwide Distributed domestically to 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, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed internationally to Canada

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: || Product Usage: || The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. || a. H74939293052030 (Material Description Innova 5 x 200 x 130); || b. H74939293052070 (Material Description Innova 5 x 200 x 75); || c. H74939293062030 (Material Description Innova 6 x 200 x 130); || d. H74939293062070 (Material Description Innova 6 x 200 x 75); || e. H74939293072030 (Material Description Innova 7 x 200 x 130); || f. H74939293072070 (Material Description Innova 7 x 200 x 75); || g. H74939293082030 (Material Description Innova 8 x 200 x 130); || h. H74939293082070 (Material Description Innova 8 x 200 x 75)

all serial numbers

Radiology Devices

2

No

Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela

GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.

all devices manufactured before November 2005

Radiology Devices

2

No

Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela

GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Imaging System.