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Medical device recalls reported in 2018

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ReportedRecallClassProductFirm
2018-05-16Z-1724-2018Class IIBEQ-TOP 25500 ECC 3/8 w/QiDDatascope Corporation
2018-05-16Z-1725-2018Class IINICU ECC Pack BEQ-TOP 39202Datascope Corporation
2018-05-16Z-1726-2018Class IIBEQ-TOP 24500 ADULT ECCDatascope Corporation
2018-05-16Z-1727-2018Class IIECC SmallDatascope Corporation
2018-05-16Z-1728-2018Class IIBEQ-TOP 22301Datascope Corporation
2018-05-16Z-1729-2018Class IIBEQ-TOP 22300Datascope Corporation
2018-05-16Z-1730-2018Class IIBEQ-TOP 41201 ECC 3/8 PUMP PACDatascope Corporation
2018-05-16Z-1731-2018Class IIBO-TOP 13901 RAPID RESPONSEDatascope Corporation
2018-05-16Z-1732-2018Class IIBO-TOP 20700 SMALL PATIENT 3/8Datascope Corporation
2018-05-16Z-1733-2018Class IIBEQ-TOP 50903 Custom ECC Pack-PedriatricDatascope Corporation
2018-05-16Z-1734-2018Class IIGentle ThreadsZimmer Biomet, Inc.
2018-05-16Z-1735-2018Class IIGentle ThreadsZimmer Biomet, Inc.
2018-05-16Z-1736-2018Class IIGentle ThreadsZimmer Biomet, Inc.
2018-05-16Z-1737-2018Class IIGentle ThreadsZimmer Biomet, Inc.
2018-05-16Z-1738-2018Class IIGentle ThreadsZimmer Biomet, Inc.
2018-05-16Z-1739-2018Class IIGentle ThreadsZimmer Biomet, Inc.
2018-05-16Z-1740-2018Class IIReNew Dolphin Nose Disposable Dissector TipMicroline Surgical, Inc.
2018-05-16Z-1741-2018Class IIReNew Endocut Scissor Disposable TipMicroline Surgical, Inc.
2018-05-16Z-1742-2018Class IIZYMUTEST HIA MonoStrip IgGHyphen BioMed
2018-05-16Z-1743-2018Class IIZYMUTEST HIA MonoStria qualitative screening assay intended for the…Hyphen BioMed
2018-05-16Z-1744-2018Class IIZYMUTEST HIA IgGAMHyphen BioMed
2018-05-16Z-1749-2018Class IILATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet…DePuy Mitek, Inc., a Johnson & Johnson Co.
2018-05-16Z-1750-2018Class IIMedtronic ZEVOMedtronic Sofamor Danek USA Inc
2018-05-16Z-1751-2018Class IIConnecting TubeCook Inc.
2018-05-16Z-1752-2018Class IIConnecting TubeCook Inc.
2018-05-16Z-1753-2018Class IIConnecting TubeCook Inc.
2018-05-16Z-1754-2018Class IIConnecting TubeCook Inc.
2018-05-16Z-1755-2018Class IIConnecting TubeCook Inc.
2018-05-16Z-1756-2018Class IIConnecting TubeCook Inc.
2018-05-16Z-1757-2018Class IIAEQUALIS HUMERAL NAIL DRILL BITTornier, Inc
2018-05-16Z-1758-2018Class IIRetractor f/Sciatic NerveSynthes (USA) Products LLC
2018-05-16Z-1759-2018Class IIRetractor f/Sciatic Nerve LongSynthes (USA) Products LLC
2018-05-16Z-1760-2018Class IIPOWERPORTBard Peripheral Vascular Inc
2018-05-16Z-1761-2018Class IIPOWERPORT ClearVUE isp with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1762-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1763-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1764-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1765-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1766-2018Class IIPOWERPORT ClearVUE isp with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1767-2018Class IIPOWERPORT ClearVUE isp with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1768-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1769-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1770-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1771-2018Class IIPOWERPORT ClearVUE Slim with Smooth SeptumBard Peripheral Vascular Inc
2018-05-16Z-1772-2018Class IIPOWERPORT ClearVUE isp Implantable Port With Smooth Septum and…Bard Peripheral Vascular Inc
2018-05-16Z-1773-2018Class IIPOWERPORT ClearVUE Slim Implantable Port with Smooth Septum and…Bard Peripheral Vascular Inc
2018-05-16Z-1775-2018Class IIHemodynamic monitoring systemICU Medical, Inc.
2018-05-16Z-1776-2018Class IITransonic ADT1018 Flow QC Clear Advantage TubingTransonic Systems Inc
2018-05-16Z-1777-2018Class IISterile Aquasonic 100 Ultrasound Transmission GelParker Laboratories, Inc.
2018-05-16Z-1778-2018Class IISyngoSiemens Medical Solutions USA, Inc
2018-05-16Z-1779-2018Class IIEasyTouchMHC Medical Products LLC
2018-05-16Z-1780-2018Class IIEasyTouchMHC Medical Products LLC
2018-05-16Z-1781-2018Class IINvisionVLE¿ Low-Profile Optical ProbeNinepoint Medical Inc.
2018-05-16Z-1782-2018Class IIOndamed Biofeedback DeviceOndamed Inc
2018-05-16Z-1783-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1784-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1785-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1786-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1787-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1788-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1789-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1790-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1791-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1792-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1793-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1794-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1795-2018Class IIJasper VektorTP Orthodontics, Inc.
2018-05-16Z-1796-2018Class IIDimension Lipase Flex¿ Reagent CartridgeSiemens Healthcare Diagnostics, Inc.
2018-05-16Z-1797-2018Class IIMicroVue BAP EIADiagnostic Hybrids, Inc.
2018-05-16Z-1798-2018Class IIFlexLabInpeco S.A.
2018-05-16Z-1799-2018Class IIISyva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL…Siemens Healthcare Diagnostics, Inc.
2018-05-16Z-1800-2018Class IIISyva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL…Siemens Healthcare Diagnostics, Inc.
2018-05-16Z-1801-2018Class IIWet-Field Hemostatic Eraser Bipolar 25GBeaver-Visitec International Inc.
2018-05-09Z-1445-2018Class IISOMATOM Emotion 6 Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1446-2018Class IISOMATOM Emotion 16 Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1447-2018Class IISOMATOM Perspective Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1448-2018Class IISOMATOM Perspective 16 Intended to produce cross-sections images of…Siemens Medical Solutions USA, Inc
2018-05-09Z-1449-2018Class IISOMATOM Scope Intended to produce cross-sections images of the body…Siemens Medical Solutions USA, Inc
2018-05-09Z-1450-2018Class IISOMATOM Scope Power Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1451-2018Class IISOMATOM Spirit Intended to produce cross-sections images of the body…Siemens Medical Solutions USA, Inc
2018-05-09Z-1452-2018Class IISOMATOM EmotionSiemens Medical Solutions USA, Inc
2018-05-09Z-1453-2018Class IISOMATOM Sensation 10 Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1454-2018Class IISOMATOM Sensation 16 Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1455-2018Class IISOMATOM Sensation Cardiac Intended to produce cross-sections images…Siemens Medical Solutions USA, Inc
2018-05-09Z-1456-2018Class IISOMATOM Sensation 64 Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1457-2018Class IISOMATOM Sensation Open Intended to produce cross-sections images of…Siemens Medical Solutions USA, Inc
2018-05-09Z-1458-2018Class IISOMATOM Sensation 40 Intended to produce cross-sections images of the…Siemens Medical Solutions USA, Inc
2018-05-09Z-1459-2018Class IISOMATOM Emotion DuoSiemens Medical Solutions USA, Inc
2018-05-09Z-1488-2018Class IIBeijing Syntech Laser Diode Laser surgical lasersBeijing Syntech Laser Co., Ltd
2018-05-09Z-1489-2018Class IIBeijing Syntech Laser Trixel C02 Laser surgical lasersBeijing Syntech Laser Co., Ltd
2018-05-09Z-1490-2018Class IIBeijing Syntech Laser Trixel 11 C02 Laser surgical lasersBeijing Syntech Laser Co., Ltd
2018-05-09Z-1491-2018Class IIBeijing Syntech Laser UL C02 Laser surgical lasersBeijing Syntech Laser Co., Ltd
2018-05-09Z-1492-2018Class IIBeijing Syntech Laser APOLLO V+ Medical Platform surgical lasersBeijing Syntech Laser Co., Ltd
2018-05-09Z-1493-2018Class IIBeijing Syntech Laser APOLLO JV+ Medical Platform surgical lasersBeijing Syntech Laser Co., Ltd
2018-05-09Z-1494-2018Class IIBeijing Syntech Laser Nice Station Light Based Platform surgical…Beijing Syntech Laser Co., Ltd
2018-05-09Z-1495-2018Class IIBeijing Syntech Laser UL Station surgical lasersBeijing Syntech Laser Co., Ltd
2018-05-09Z-1537-2018Class IIModular Head ComponentZimmer Biomet, Inc.
2018-05-09Z-1538-2018Class IIModular Head ComponentZimmer Biomet, Inc.
2018-05-09Z-1539-2018Class IIWET-FIELD OSHER THERMODOT MARKERBeaver-Visitec International Inc.
2018-05-09Z-1540-2018Class IIDimension Vista¿ Calcium Flex¿ reagent cartridgeSiemens Healthcare Diagnostics, Inc.
2018-05-09Z-1541-2018Class IISpecimen Gate Screening CenterPerkinElmer Life and Analytical Sciences, Wallac, OY
2018-05-09Z-1542-2018Class IIIAlere iScreen Dx Urine Drug Screen CardAmeditech Inc
2018-05-09Z-1543-2018Class IIPTS Panels¿ CHOL+GLU Test StripsPolymer Technology Systems, Inc.
2018-05-09Z-1544-2018Class IIIBD MAX DNA MMKBecton Dickinson & Co.
2018-05-09Z-1545-2018Class IIIBD MAX DNA MMK Lab UseBecton Dickinson & Co.
2018-05-09Z-1546-2018Class IIMedi-VacCardinal Health 200, LLC
2018-05-09Z-1582-2018Class IIAQURERadiometer Medical ApS
2018-05-09Z-1583-2018Class IIDeRoyalDeRoyal Industries Inc
2018-05-09Z-1584-2018Class II5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip TrocarCooperSurgical, Inc.
2018-05-09Z-1585-2018Class IIMHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear…Hitachi Ltd., Medical System Operations Group
2018-05-09Z-1586-2018Class IIAtelia IM 1300 Analyzer for in vitro diagnostic testing of clinical…Siemens Healthcare Diagnostics, Inc.
2018-05-09Z-1587-2018Class IIAtellica Solution and Atellica Sample Handler Prime for in vitro…Siemens Healthcare Diagnostics, Inc.
2018-05-09Z-1588-2018Class IIAnalyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic…Siemens Healthcare Diagnostics, Inc.
2018-05-09Z-1589-2018Class IIAllura Xper R8Philips Electronics North America Corporation
2018-05-09Z-1590-2018Class IIStoneBreaker Pneumatic LithotripterCook Inc.
2018-05-09Z-1591-2018Class IIStoneBreaker Exhaust CapCook Inc.
2018-05-09Z-1592-2018Class IIStoneBreaker Exhaust LineCook Inc.
2018-05-09Z-1593-2018Class IIStoneBreaker Probe CapCook Inc.
2018-05-09Z-1594-2018Class IIStoneBreaker Sterilization CapCook Inc.
2018-05-09Z-1595-2018Class IIStoneBreaker C02 CartridgeCook Inc.
2018-05-09Z-1596-2018Class IIStoneBreaker Single Use ProbeCook Inc.
2018-05-09Z-1597-2018Class IIBiograph HorizonSiemens Medical Solutions USA, Inc.
2018-05-09Z-1598-2018Class II6376 M-1 Cot FastenerStryker Medical Division of Stryker Corporation
2018-05-09Z-1599-2018Class II6381 M-1 Cot FastenerStryker Medical Division of Stryker Corporation
2018-05-09Z-1600-2018Class IIHYPOTHERMIA CAP Supportive in CancerSouthwest Technologies Inc
2018-05-09Z-1601-2018Class IIHYPOTHERMIA MITTS Supportive in CancerSouthwest Technologies Inc
2018-05-09Z-1602-2018Class IIHYPOTHERMIA SLIPPERS Supportive in CancerSouthwest Technologies Inc
2018-05-09Z-1603-2018Class IIMultiDim Eleva 708032 As a multifunctional universal imaging…Philips Medical Systems Nederlands
2018-05-09Z-1604-2018Class II708033 URODiagnost As a multifunctional universal imaging application…Philips Medical Systems Nederlands
2018-05-09Z-1605-2018Class IIMultiDiagnost Eleva 708036 As a multifunctional universal imaging…Philips Medical Systems Nederlands
2018-05-09Z-1606-2018Class IIMutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional…Philips Medical Systems Nederlands
2018-05-09Z-1607-2018Class IIMutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector…Philips Medical Systems Nederlands
2018-05-09Z-1608-2018Class IIMultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional…Philips Medical Systems Nederlands
2018-05-09Z-1609-2018Class IIMultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional…Philips Medical Systems Nederlands
2018-05-09Z-1610-2018Class IIcobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and…Roche Diagnostics Corporation
2018-05-09Z-1611-2018Class IICobas b 221<4>Roche OMNI S4 systemRoche Diagnostics Corporation
2018-05-09Z-1612-2018Class IIcobas b 221<6>Roche OMNI S6 systemRoche Diagnostics Corporation
2018-05-09Z-1613-2018Class IIcobas b 221 AutoQC Module CompleteRoche Diagnostics Corporation
2018-05-09Z-1615-2018Class IIMiriam Capsule Endoscope SystemIntroMedic Co., Ltd.
2018-05-09Z-1627-2018Class IINanosil Spray GelConseal International, Inc.
2018-05-09Z-1628-2018Class IITeleflex MEDICAL LMATeleflex Medical Europe Ltd
2018-05-02Z-1361-2018Class IICrimson Trace Corporation laser sightsCrimson Trace Corporation
2018-05-02Z-1462-2018Class IITriathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601…Howmedica Osteonics Corp.
2018-05-02Z-1463-2018Class IIThe humeral stems trials are packaged in a kit for Titan Modular…Integra LifeSciences Corp.
2018-05-02Z-1464-2018Class IIDouble Blade Shoe F/Unigraft Knife 1Ace Surgical Supply Co., Inc.
2018-05-02Z-1465-2018Class IIM/DN Intramedullary Fixation Humeral Guide WireZimmer Biomet, Inc.
2018-05-02Z-1466-2018Class IIHumeral Guide Wire Ball Tip 2Zimmer Biomet, Inc.
2018-05-02Z-1467-2018Class IIZimmer Natural Nail System Tear Drop Guide Wire 3Zimmer Biomet, Inc.
2018-05-02Z-1468-2018Class IIZimmer Natural Nail System Tear Drop Guide Wire 2Zimmer Biomet, Inc.
2018-05-02Z-1469-2018Class IIZimmer Natural Nail System Tear Drop Guide Wire 3Zimmer Biomet, Inc.
2018-05-02Z-1470-2018Class IIZMS Intramedullary Fixation Smooth Guide Wire 3Zimmer Biomet, Inc.
2018-05-02Z-1471-2018Class IIPressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip…Zimmer Biomet, Inc.
2018-05-02Z-1472-2018Class IIZimmer Natural Nail System Tear Drop Guide Wire 2Zimmer Biomet, Inc.
2018-05-02Z-1473-2018Class IISmooth Guide Wire Bullet Tip 3Zimmer Biomet, Inc.
2018-05-02Z-1474-2018Class IIM/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2Zimmer Biomet, Inc.
2018-05-02Z-1475-2018Class IIZMS Intramedullary Fixation Smooth Guide Wire 2Zimmer Biomet, Inc.
2018-05-02Z-1476-2018Class IIZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3Zimmer Biomet, Inc.
2018-05-02Z-1477-2018Class IIProteus 235Ion Beam Applications S.A.
2018-05-02Z-1478-2018Class IIFlowmeter ModuleTerumo Cardiovascular Systems Corporation
2018-05-02Z-1479-2018Class IIMedtronic DxTerity Diagnostic CatheterMedtronic Vascular
2018-05-02Z-1480-2018Class IIOncomine Dx Target TestLife Technologies Corporation
2018-05-02Z-1485-2018Class IIGenesis Surgical Cassette Tapered Implants are intended for placement…Keystone Dental Inc
2018-05-02Z-1486-2018Class IIADVIA Centaur CA 125II AssaySiemens Healthcare Diagnostics, Inc
2018-05-02Z-1487-2018Class IITCC-EZIntegra LifeSciences Corp.
2018-05-02Z-1496-2018Class IIMicroVue CIC-C1q EIADiagnostic Hybrids, Inc.
2018-05-02Z-1497-2018Class IIIMicroVue CIC-C1q EIADiagnostic Hybrids, Inc.
2018-05-02Z-1498-2018Class IIIMicroVue SC5b-9 Plus EIADiagnostic Hybrids, Inc.
2018-05-02Z-1499-2018Class IIIMicroVue SC5b-9 Plus EIADiagnostic Hybrids, Inc.
2018-05-02Z-1500-2018Class IIT4 Pullover TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1501-2018Class IIT4 Pullover TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1502-2018Class IIT4 Pullover TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1503-2018Class IIT4 Pullover TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1504-2018Class IIT4 Pullover TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1505-2018Class IIT4 Zipper TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1506-2018Class IIT4 Zipper TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1507-2018Class IIT5 Zipper Toga with Peel-Away Face ShieldStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1508-2018Class IIT4 Zipper TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1509-2018Class IIT4 Zipper TogaStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1510-2018Class IIT5 Zipper Toga with Peel-Away Face ShieldStryker Instruments Div. of Stryker Corporation
2018-05-02Z-1511-2018Class IIFlex Arm Product Usage: The Synthes Flex Arm is a component of the…Synthes, Inc.
2018-05-02Z-1512-2018Class IIKnee ProsthesisHowmedica Osteonics Corp.
2018-05-02Z-1513-2018Class IIFilmArray BCID PanelBioFire Diagnostics, LLC
2018-05-02Z-1514-2018Class IIStem Extractor f/Guide BarSynthes, Inc.
2018-05-02Z-1515-2018Class IIIclariti 1 day/Fresh Day 90 packCooperVision Inc.
2018-05-02Z-1516-2018Class IIIclariti 1 dayCooperVision Inc.
2018-05-02Z-1517-2018Class III56% 1 Day Silicone HydrogelCooperVision Inc.
2018-05-02Z-1518-2018Class III56% 1 Day Silicone HydrogelCooperVision Inc.
2018-05-02Z-1519-2018Class IIRoche Acetaminophen assay 03255379160-HAcetaminophenRoche Diagnostics Corporation
2018-05-02Z-1520-2018Class IIIQuidel MicroVue Intact PTH EIADiagnostic Hybrids, Inc.
2018-05-02Z-1521-2018Class IIAdvance¿ 35LP Low-Profile PTA Balloon Dilatation CatheterCook Inc.
2018-05-02Z-1522-2018Class IIOrthopedic Salvage SystemZimmer Biomet, Inc.
2018-05-02Z-1523-2018Class IIVersatex Monofilament Mesh 50 x 50cmSofradim Production
2018-05-02Z-1524-2018Class IIAvenir Muller StemZimmer GmbH
2018-05-02Z-1525-2018Class IIAvenir Muller StemZimmer GmbH
2018-05-02Z-1526-2018Class IIHinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for…Stryker GmbH
2018-05-02Z-1527-2018Class IIEEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3Covidien LLC
2018-05-02Z-1528-2018Class IIEEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4Covidien LLC
2018-05-02Z-1529-2018Class IIAccelerate PhenoTest BC kitAccelerate Diagnostics Inc
2018-05-02Z-1530-2018Class IICELLSEARCH¿ CIRCULATING Tumor Cell KitsMenarini Silicon Biosystems
2018-05-02Z-1531-2018Class IIBD Vacutainer¿ Push Button Blood Collection Set 0Becton Dickinson & Company

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