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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para Trade name: POCKET ADAPTER EXTENSION ADAPTER. ANVISA registry number: 10339190354. Class of risk: IV. Affected model (s): 64001 and 64002 2016-06-21 Brazil ANVISA
Alerta De Seguridad para Trade name: ACUSON SC2000 ULTRASOUND DIAGNOSTIC SYSTEM. Technical Name: Ultrasound Device. ANVISA Registry No. 10345161999. Risk class: II (Medium Risk). Model: ACUSON SC2000. Serial numbers: 400294; 401532; 401704; 402705; 402766 2016-07-08 Brazil ANVISA
Alerta De Seguridad para Trade name: Cabo Fresa Femural. ANVISA registration number: 80005430069. Hazard class: I. Model (s) concerned: CODE 09309003. All lots manufactured between January 1995 and October 2005. 2016-06-22 Brazil ANVISA
Alerta De Seguridad para Trade name: Cabo Fresa Femural. ANVISA registration number: 80005430069. Hazard class: I. Model (s) concerned: CODE 09309003. All lots manufactured between January 1995 and October 2005. 2016-06-22 Brazil ANVISA
Notificaciones De Seguridad De Campo acerca de triage bnp calibrator lot 328163 2014-06-12 Poland ORMPMDBP
Alerta De Seguridad para Product Category: Angiography Equipment Allura Xper. Registration number ANVISA: 10216710153. Class of risk: III. Allura Xper FD1O / Allura Xper FD1O / 10 Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD1O / Allura Xper FD1O / Allura / Allure Xper FD2O / 1 / Allura Xper FD2O / 1 5 OR Table. List of lots / series: 285/306/308/322/379/565/405/639 2016-06-23 Brazil ANVISA
Alerta De Seguridad para Trade name: COAGUCHEK XS PT TESTSTRIPS 6 tests //. Technical name: SELF-TEST FOR COAGULATION PARAMETERS //. ANVISA registration number: 10287410553 //. Risk class: III (High Risk) //. Affected lots: 11911822; 20646321; 20335921; 23343322; 23194921; 23073621 2016-07-29 Brazil ANVISA
Alerta De Seguridad para Trade name: /// (1). EQUIPMENT FOR ANGIOGRAPHY ARTIS (Record 10345162023) - Models: (i). Artis zee floor; (ii). Artis zee ceiling; (iii). Artis zeego; (iv). Artis Q biplane; (v). Artis zee biplane /// (2). AXIOM ARTIS FC AXIOM (Record 10234230075) - Model Artis FC /// (3). AXIOM ARTIS FA AXIOM (Record10234230093) - Model Artis FA /// (4). AXIOM ANGIOGRAPHY EQUIPMENT (Registration 10234230096) - Models: (i). Artis dFA; (ii). Artis dFC ### Technical Name: Angiography Equipment ### ANVISA Registration Number: (1). ARTIS EQUIPMENT FOR ANGIOGRAPHY (Record 10345162023) /// (2). AXIOM ARTIS FC AXIOM (Registration 10234230075) /// (3). AXIOM ARTIS FA AXIOM (Registro10234230093) /// (4). AXIOM ANGIOGRAPHY EQUIPMENT (Registration 10234230096) ### Risk Class: III (High Risk) ### Affected Series Numbers: APPENDIX 2016-08-25 Brazil ANVISA
Alerta De Seguridad para Misago Self-expanding Peripheral Stent ### Technical Name: Misago Self-Expansion Peripheral Stent ### Registration Number ANVISA: 80012280143 ### Risk Class: III (High Risk) ### ) affected: ALL ### Lot (s): EVERYTHING AND ANY LOT MANUFACTURED SINCE 2013 2016-08-25 Brazil ANVISA
Alerta De Seguridad para Intracranial Pressure Monitor /// Technical Name: Intracranial Pressure Monitor /// ANVISA Record Number: 10175060014 /// Risk Class: III - High Risk /// Model Affected: 06019411 - Neuro Intracranial Pressure Monitor I Plus /// Affected Lot Numbers: See Distribution Map 2016-08-31 Brazil ANVISA
Alerta De Seguridad para CELL-DYN Emerald Cleaner / CELL-DYN Emerald Cleaner Registration Number ANVISA: 80146501650 ### Hazard Class: I (PRODUCTS OF LOW RISK TO INDIVIDUAL AND LOW RISK TO PUBLIC HEALTH, SUBJECT TO REGISTRATION) ### Lot : 7044 2016-08-25 Brazil ANVISA
Alerta De Seguridad para Product name: Vital Signs Monitor ### Anvisa Record Number: 10216710215 ### Risk Class: III (High Risk) ### Affected Models: MX400, MX430 , MX450, MX500, MX550 ### Affected serial numbers: APPENDIX 2016-08-25 Brazil ANVISA
Alerta De Seguridad para Product name: Thyroxine (T4) ### Registration number ANVISA: 10132590400 ### Hazard class: II ### Product code: 8744468 ## Trademark: IMMUNODIAGNOSTIC REAGENT KIT VITROS * ECi FOR TOTAL T4 ### Technical Name: # Batch numbers affected: 1845; 1880; 1900; 1930; 1950 2016-08-25 Brazil ANVISA
Alerta De Seguridad para Trade name: Accessories for Liquor System ###. Technical Name: Infusion Port Catheter ###. ANVISA registration number: 10175060023 ###. Risk Class: IV (Maximum Risk) ###. Affected Model: ###. Batch numbers affected: AUTO087510 / 515, AUTO084109 / 240, AUTO088695 / 635, AUTO087642 / 526, AUTO088287 / 589, AUTO087772 / 561, AUTO088695 / 632 2016-08-19 Brazil ANVISA
Alerta De Seguridad para Trade Name: BAG FOR BLOOD COLLECTION CPDA-1 /// Technical Name: BLOOD BAG /// ANVISA Registration Number: 10154450085 /// Risk Class: III - High Risk /// Model: Triple Bag with Plasticizers DEHP and TOTM - Composampler /// Serial numbers affected: 71KA18AA00. 2016-07-15 Brazil ANVISA
Alerta De Seguridad para Trade name: VIDEODUODENOSCOPIO ###. Technical name: VIDEODUODENOSCOPIO ###. ANVISA registration number: 80124630021 ###. Risk class: II (Medium Risk) ###. Model Affected: TJF-160VF / TJF-160F ###. Affected Lot Numbers: 2802533, 2103207, 2103215, 2103214, 2802547, 2003129, 2103203, 2203242, 2303243, 2303244, 2103226, 2103221, 2103205, 2103209, 2103194, 2103202, 2500817, 2003172, 2802085, 2701664, 2802134, 2103199, 2302248 , 2701768, 2103208, 2701843, 2701851, 2003135, 2902744, 2902746, 2103223, 2701978, 2902846, 2902870, 2602725, 2802115, 2302325, 2902995, 2103200, 2003139, 2802551, 2902901, 2602730, 2802118, 2802281, 2602728, 2903001, 2103197 , 2103201, 2802590, 2802591, 2802592, 2902834, 2902835, 2802138, 2902787, 2902836, 2701791, 2701807. 2016-08-15 Brazil ANVISA
Alerta De Seguridad para Trade name: LINEAR DIGITAL ARTISTE ACCELERATOR ###. Technical Name: LINEAR THROTTLE ###. ANVISA registration number: 10234230172 ###. Risk class: III (High Risk) ###. Affected template: Artiste ###. Number of series affected: 10233; 10321 2016-08-26 Brazil ANVISA
Alerta De Seguridad para Commercial Name / Technical Name: FAMILY OF DISCS AND TAPES IMPREGNATED WITH ANTIMICROBIAL AGENTS OR GROUPS - Presentation / Commercial Model: CEFTAZIDIME CAZ 10 - Registration 10349280238 - Risk Class II (Medium Risk) - Model CT1629B - Lot 1426486.// 2016-08-22 Brazil ANVISA
Alerta De Seguridad para Commercial Name: VITROS ECI FOR IMMUNODIAGNOSTIC REAGENT KIT FOR ESTRADIOL //. Technical Name: 30321 Estradiol // Registration 10132590405 - Risk Class II (Medium Risk) // Product code 8552630 // Lots affected and imported in Brazil: 1470, 1480, 1490, 1500, 1510, 1528, 1538, 1548, 1558 , 1568.// 2016-08-17 Brazil ANVISA
Alerta De Seguridad para Trade name: Ventilator /// Anvisa Registration n ° 80047300528 /// Technical name: Fan Pressure and Volume /// Risk class: III (High Risk) ///; Affected model (s): Astral 100 / Astral 150 /// Serial number (s) affected: See Annex. 2016-09-06 Brazil ANVISA
Alerta De Seguridad para Commercial Name: External Drainage Catheter Antimicrobial LCR ## Record Number: 10175060026 ## Technical Name: Drainage System ## Risk Class: IV (Maximum Hazard) ## Models: 04019724- Antimicrobial LCR External Drainage Catheter - Adult Model , 04019725 - LCR Antimicrobial External Drainage Catheter - Neonatal Model 2016-09-14 Brazil ANVISA
Alerta De Seguridad para Commercial name of the product: PCR Eleva /// Registration number: 10216719006 /// Models affected: S / S Plus / S Hi-res / Cosimax / Corado / Compact /// Serial number affected: 36626334./// Class risk of the product: I. 2016-09-16 Brazil ANVISA
Alerta De Seguridad para Commercial name: BD Phoenix Gram Negative /// Technical name: Identification device / antibiogram of microorganisms /// ANVISA registration number: 10033430636 /// Risk class: II /// Whereas cefepime is present in BD Phoenix panels Gram Negatives, all panels that are already used, ie panels already registered with ANVISA, and potential panels to be used, ie panels that are to be registered, were included in the Client Notification. Registered panels: BD Phoenix NMIC / ID - 123; BD Phoenix NMIC-123; BD Phoenix NMIC-129; BD Phoenix NMIC / ID-124; BD Phoenix NMIC / ID-126; BD Phoenix NMIC / ID-129; BD Phoenix NMIC / ID-132; BD Phoenix NMIC-133; BD Phoenix NMIC / ID-121; BD Phoenix NMIC-140; BD Phoenix NMIC / ID-94; BD Phoenix NMIC - 203 // Panels to be registered: BD Phoenix NMIC / ID-406; BD Phoenix NMIC-406; BD Phoenix UNMIC / ID-407; BD Phoenix UNMIC-407. 2016-09-14 Brazil ANVISA
Alerta De Seguridad para Trade name: Valvulotomo Hydro Lemaitre Longo. Technical Name: Valvulotomo. ANVISA registration number: 80202919003. Class of risk: II. Affected Model:. Serial numbers affected: ELVH1082V 2016-09-14 Brazil ANVISA
Alerta De Seguridad para Commercial Name: External Drainage Catheter LCR Ventura /// Technical Name: Drainage System /// ANVISA Registration Number: 10175060016 /// Hazard Class: IV - Maximum Risk /// Model Affected: LCR 600A (Adult Model) , LCR 600N (Neonatal Model) and LCR 600H (Hemovent) /// Affected Lot Numbers: See Distribution Map 2016-09-14 Brazil ANVISA