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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para 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 2018-06-04 Brazil ANVISA
Alerta De Seguridad para 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 2018-06-04 Brazil ANVISA
Alerta De Seguridad para 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 2018-06-04 Brazil ANVISA
Alerta De Seguridad para 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. 2018-06-04 Brazil ANVISA
Alerta De Seguridad para 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 2018-06-04 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-30 Brazil ANVISA
Alerta De Seguridad para 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. 2018-05-30 Brazil ANVISA
Alerta De Seguridad para 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. 2018-05-29 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-28 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-28 Brazil ANVISA
Alerta De Seguridad para 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. 2018-05-25 Brazil ANVISA
Alerta De Seguridad para 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. 2018-05-23 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-23 Brazil ANVISA
Alerta De Seguridad para 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. 2018-05-23 Brazil ANVISA
Alerta De Seguridad para 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. 2018-05-09 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-09 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-09 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-09 Brazil ANVISA
Alerta De Seguridad para 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" 2018-05-07 Brazil ANVISA
Alerta De Seguridad para 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. 2018-05-07 Brazil ANVISA
Alerta De Seguridad para 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. " 2018-05-07 Brazil ANVISA
Alerta De Seguridad para 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." 2018-05-07 Brazil ANVISA
Alerta De Seguridad para 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 2018-05-04 Brazil ANVISA
Alerta De Seguridad para Trade name: Ultrasound System (ANVISA Registration 80035360066); LOGIQ 9 (ANVISA Registry 80035360066); LOGIQ E9 (ANVISA registration 80071260213); Vivid 7 (ANVISA registry 80071260187); Vivid E9 (ANVISA registration 80071260207); Vivid E80, Vivid E90 and Vivid E95 (ANVISA registration 80071260361). Technical Name: Ultrasound System. ANVISA registration number: 80035360066; 80071260213; 80071260187; 80071260207; 80071260361 .. Class of risk: II. Affected model: Logiq 9. Affected batches / series numbers: equipment installed since April 2015 or have been replaced with power cable since April 2015. 2018-05-04 Brazil ANVISA
Alerta De Seguridad para Trade name: Spectra Optia Apheresis System. Technical Name: Apheresis System. ANVISA registration number: 80554210002. Class of risk: III. Model affected: -. Batched / affected series numbers: All devices. 2018-05-04 Brazil ANVISA