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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Trade name: Elecsys Vitamin D total II. Technical name: Vitamin D. ANVISA registration number: 10287411273. Class of risk: II. Model Affected: N / A. Elecsys Vitamin D total II (100 tests) (Code: 7464215190 and Record: 10287411273) lots under risk in Brazil: 27398201/29822801 / 27398202. Elecsys Vitamin D total II (300 tests) (Code: 7028148190 and Registry: 10287411242) lots under risk in Brazil: 23010601/27396201 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH Brazil ANVISA
Trade name: SURGICAL INSTRUMENTS. Technical Name: INSTRUMENTAL NON-ARTICULATED NON-CUTTING. ANVISA registration number: 80145901733. Risk class: I - LOW RISK. Affected Model: Pin Pullers and Screws. Serial numbers affected: "Cod .: 03.401.072 || Lot 10-2637 .. Cod .: 03.401.077 || Lot 10-4566." Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; SYNTHES GMBH Brazil ANVISA
Trade name: Askina Calgitrol Paste 15 gr and Askina Gel 15 gr. Technical name: Askina Calgitrol Paste 15 gr and Askina Gel 15 gr. ANVISA registration number: 80136990789. Risk class: III. Affected template: 6241505, 001419SBR and 001419S. Affected serial numbers: Code 001419S: 514031, 514033 and 518472 ;. Code 001419SBR: 485431, 504281, 485431 and 504281 ;. Code 6241505: P2408, P2460, P2469, P2481, P2524, P2528, P2549, P2552, P2556 and P2577. " Laboratórios B. Braun S.A.; B.Braun Melsungen AG Brazil ANVISA
Commercial Name: BD Vacutainer Plastic Tube with Reagent for Vacuum Blood Collection. Technical name: Vacuum blood collection tube. Registration number ANVISA: 10033430470. Hazard class: I. Model affected: TUBE VACUTAINER CITRATE (9NC) 0,109M TAMPA HEMOGARD 2,7mL. Affected serial numbers: Lots #: 7180812, 7180813, 7180814, 7214941, 7214943, 7305988, 7346905, 7346912 and 8011842. Becton Dickinson Indústrias Cirúrgicas Ltda; Becton, Dickinson and Company Brazil ANVISA
Trade name: Aesculap single use bipolar instrument. Technical name: Aesculap single use bipolar instrument. ANVISA registration number: 80136990832. Risk class: III. Model affected: Caiman 5 mm. Affected Batches / Series Numbers: See Attachment "List of Batches Under Risk" Laboratórios B. Braun S.A.; Aesculap AG Brazil ANVISA
Trade Name: SCITECH CATCH TIE. Technical Name: Filters. ANVISA registration number: 10413960200. Risk Class: II. Model affected: NA. Serial numbers affected: 111624 - LACO SNARE SCITECH 4FR 05MM X 120CM KIT. 112000 - LACO SNARE SCITECH 5FR 15MM X 120CM KIT. Lots: 023843, 024004, 024494, 024498, 024895 and 025282 Scitech Produtos Médicos Ltda.; Scitech Produtos Médicos Ltda. Brazil ANVISA
Commercial Name: X-ray Apparatus. Technical Name: Fixed X-ray Apparatus. ANVISA registration number: 10216710166. Risk Class: III. Model Affected: OmniDiagnost Elevates. Serial numbers affected: 317 Philips Medical Systems Ltda; Philips Medical Systems DMC GmbH Brazil ANVISA
Trade Name: HbA1c KIT. Technical Name: Glycosylated hemoglobin. ANVISA registration number: 80115310145. Risk Class: II. Model affected: R1: 2x15mL + R2: 1x10mL + R3: 1x5mL. Serial numbers affected: 1084091744, 1084091745, 1084091846 KOVALENT DO BRASIL LTDA; KOVALENT DO BRASIL Brazil ANVISA
Trade Name: Urisys 1100. Technical Name: Instrument for urinalysis. ANVISA Registration Number: 10287410738. Hazard Class: I. Model Affected: N / A. Serial numbers affected: Destruction: UX09612510; UX09628084; UX09631442. Active: UX09656469. Stock: 9629877; UX09627628; 9629878; UX09642188. Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH - Sandhofer Strasse 116 - 68305 - Alemanha Brazil ANVISA
Commercial Name: Optima Magnetic Resonance Imaging System. Technical Name: Magnetic Resonance Equipment. ANVISA registration number: 80071260300. Risk Class: II. Model affected: OPTIMA MR450w GEM. Serial numbers affected: 00000014131M67; 00000018480M64; 00000021158M61. All "MR Surgical Suite" tables that use mobile patient transfer plate between the GE table (model M0074SS) and the Surgical Magnus Maquet table with 1150 or 1180 table tops. GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE MEDICAL SYSTEMS LLC Brazil ANVISA
Trade Name: Transfer Kit for Exactamix. Technical Name: Transfer Kit for Exactamix. ANVISA registration number: 80145240403. Class of Risk: II. Affected Model: H938173 | H938174 | H938175 | H938176. Serial numbers affected: 802385 | 802279 | 802281 | 802284 Baxter Hospitalar; Baxter Healthcare Co. Brazil ANVISA
Trade Name: Sterile Operating Field Technical Name: Surgical Field ANVISA Registration Number: 8003740007 Hazard Class: II Model Affected: Sterile Operating Field 25X28CM Serial Numbers Affected: LOT: 034-2 FAB: 3/19/2018. America Medical Ltda; America Medical Brazil ANVISA
Commercial Name: Computed Tomography System / CT Scanner. Technical Name: Computerized Tomographic Equipment. ANVISA registration number: 80071260079. Risk Class: III. Affected Model: Optima CT 540, BRIGHTSPEED ELITE 16 SLICE EDITION, Optima CT 540 Mobile, OPTIMA CT 660, REVOLUTION EVO, Optima CT 660 Cj 3.5 (80071260119 and 80071260079). Serial numbers affected: CJRAX1600072CN; CJRAX1700001CN; CJRAX1700002CN; CJRMX1600005CN; JRMX1600011CN; CJRMX1600012CN; CJRMX1600013CN; CJRMX1600014CN; CJRMX1600018CN; CJRMX1600019CN; 00000030120YC0; 00000030500YC3; 00000033404YC5; 00000033973YC9; 00000035290YC6; 00000428317CN2; 00000429355CN1; 00000429530CN9; 00000437168CN8; 00000437278CN5; 00000441652CN5; 00000441968CN5; CBAQG1600010HM. GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE HEALTHCARE JAPAN CORPORATION; GE HEALTHCARE DO BRASIL COM. E SERV. P/ EQUIP. MÉDICO-HOSPITALARES LTDA.; GE MEDICAL SYSTEMS LLC.; GE HANGWEI MEDICAL SYSTEMS CO, LTD. Brazil ANVISA
Trade Name: MagNA Pure 24 System. Technical Name: Instrument for analysis of nucleic acids. ANVISA registration number: 10287411309. Risk Class: II. Model Affected: N / A. Serial numbers affected: Active: 1119 | Inventory: 1162 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH Brazil ANVISA
Commercial Name: Angiography Equipment Artis. Technical Name: Angiography Equipment. ANVISA registration number: 10345162023. Risk Class: III. Model affected: Artis zee ceilling; Artis zeego. Serial numbers affected: 147619; 160836; 160843 Siemens Healthcare Diagnósticos Ltda; SIEMENS HEALTHCARE GMBH Brazil ANVISA
Trade Name: Harmonic Ace Shears and Adaptive Tissue Technology. Technical Name: Electrosurgical Cable (Power greater than 50W). ANVISA registration number: 80145901455. Risk Class: III. Model affected: HAR23; HAR36. Affected Serial Numbers: Codes and batch numbers related to each code, for individually marketed affected products, and for kits containing affected products are shown in the Customer Letter attached to this Alert. Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; Ethicon Endo-Surgery LLC Brazil ANVISA
Business Name: Heartware - Ventricular Assist System. Technical Name: Intracardiac Pump. ANVISA registration number: 10339190685. Risk Class: IV. Affected Model: All components that are part of the Heartware Ventricular Assist System. Serial numbers affected: bat013046; bat013114; BAT013820; BAT013825; BAT014350; BAT014351; BAT014352; BAT014353; BAT015058; BAT015059; BAT015060; BAT015061; BAT015062; BAT015065; BAT015066; BAT015070; BAT030136; BAT030210; BAT030245; BAT030247; BAT091007; BAT091113; BAT091133; BAT091137; BAT091139; BAT092750; BAT092755; BAT092781; BAT092793; BAT092795; BAT092802; BAT092807; BAT200397; BAT200399; BAT200479; BAT200484; BAT200488; BAT200519; BAT200550; BAT200552; BAT200621; BAT200678; BAT200720; BAT200771; BAT200772. Medtronic Comercial Ltda; HeartWare, Inc Brazil ANVISA
Trade Name: Intra-Aortic Balloon Pump. . Technical Name: Intra-Aortic Balloon Pump System. . ANVISA registration number: 10390690062.. Risk Class: III. . Model affected: CARDIOSAVE. . Serial numbers affected: CH207880C5; CH245699K6 Maquet Cardiopulmonary do Brasil Industria e Comercio Ltda.; Datascope Corp. Brazil ANVISA
Trade Name: Bardport Port Fully Implantable in Titanium and Silicon; Fully Implantable Bardport in Plastic and Silicone; Port Implanted X-Port Isp with Silicone Catheter and Peel-Apart Bard Introducer Kit; Powerport Chronoflex Open End Mri; Powerport Catheter Groshong Valvular Mri. Technical Name: Infusion Catheter; Infusion Port Catheter. ANVISA registration number :. 80689090126; 80689090128; 80689090136; 80689090103; 80689090105. Hazard Class: IV. Affected model: Titanium Ports (base diameter: 31.7 mm, height: 14.5 mm, weight: 15.4 g); Port Titanium Dome (base diameter: 27.2 mm, height: 15 mm, weight: 7.9 g); MRI Ports Low Profile (base diameter: 24.8 mm, height: 10 mm, weight: 3.2 g); connectable; 8 Fr - Polyurethane catheter without suture plug; 8F MRI without suture plug, single lumen .. Serial Numbers Affected: Code Lot Number: 0602240 REBT0050; 0602850 REBT0345; 0603870 REBT2330; 0607555 REBT2153; 0607555 REBV1315; 8808061 REBU0499; 8808561 REBU1200 Bard do Brasil Industria e Comercio de Produtos para Saude Ltda; Bard Access Systems, Inc Brazil ANVISA
Identification of the product or case :. Trade Name: BD Posiflush Heparin Lock Flush Syringe. Technical Name: Disposable Syringes. Registration number ANVISA: 10033430366. Class of Risk: IV. Affected model: BD Posiflush Syringe with Heparin, USP, 300 units / 3mL (100 units / mL) - 3mL in 10mL syringe. Serial numbers affected: Lots #: 708782N and 709772N. Becton Dickinson Indústrias Cirúrgicas Ltda; Becton, Dickinson and Company Brazil ANVISA
Commercial Name: Prismaflex Monitor. Technical Name: Prismaflex Control Unit. ANVISA registration number: 80145240438. Risk Class: III. Affected Model: 955052, 114489, 107493 and 113082. Serial numbers affected: See Attached List, Attachment 1 Baxter Hospitalar; Gambro Industries Brazil ANVISA
Trade Name: Load for Endo Gia Universal Stapler with Tri-Staple Technology. Technical Name: Clamps. ANVISA registration number: 10349000296. Class of Risk: III. Model Affected: EGIA45AMT; EGIA45AVM; EGIA45AXT; EGIA60AMT; EGIA60AXT; EGIA60AXT; EGIA45AMT; EGIA45AVM; EGIA60AMT; EGIA45AXT. Serial numbers affected: N7L1057KX; N7L0551KX; N7M0877KX; N8A0146KX; N8A0907KX; N8A0488KX; N7M0853KX; N7M0486KX; N7L0974KX; N8A0363KX; N7L0521KX; N7L1038KX Auto Suture do Brasil Ltda; Covidien Llc Brazil ANVISA
Trade Name: Articular Cannulas with MAQUET Reinforcement. Technical Name: Cannulae. ANVISA registration number: 10390690100. Risk Class: IV. Affected Model: Articular Cannulas with MAQUET Reinforcement. Serial numbers affected: A202107; A222107; A242107; ACR0890V; ACR1890V; AS18V; AS21V; AS24V Maquet Cardiopulmonary do Brasil Industria e Comercio Ltda. Brazil ANVISA