Dispositivos

Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Surgical gloves and Gloves for non-surgical procedures must meet the technical requirements defined by the Brazilian certification body (Inmetro), have the manufacturing batch number and number of the CA printed on each glove, as well as the Conformity Identification Seal on the packaging . N/A Brazil
VITROS IMMUNODIAGNOSIS CONTROL FOR ONCOLOGY - LOT 0220 - Code 1935543 - Registered in Anvisa under the number 10132590516. Johnson & Johnson do Brasil Indústria e Comércio de Produtos para a Saúde Ltda. Brazil
NON-SPECIFIC SYSTEMS FOR GLYCOSIS - MEASURING DEVICES AND RIBBON TESTS OF GLYCOSYDYDROGENASE WITH PYRROLOQUINONE QUINONE (GDH-PQQ) from all manufacturers. N/A Brazil
BARD MAGNUM BIOCHEMICAL DISPOSABLE NEEDLE. Anvisa Registration: 10178010157. Product codes: MN1610, MN1613, MN1616 and MN1620. Lots Affected: see annex in http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/993_lista_produtos.pdf. Politec Importação e Comércio Ltda. Brazil
GYNECARE MORCELLEX FABRIC CLEANER. MODEL: MX0100. Registro Anvisa 80145901131. Lots affected: See annex at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/994_lotes_afetados.pdf. Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda. Brazil
CATETER BALAO EQUALIZER - Registered at Anvisa under the number 10341350413. Model / Lot: See attachment at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/995_lista_produtos.pdf Boston Scientific do Brasil Ltda. Brazil
REVISCULARIZATION DEVICE PENUMBRA - Registered in Anvisa under the number 80102510509 - Serial Numbers: F13242; F14138; F15141; F13607; F13801; F14346; F15105; F15150; F13901; F14842; F15173. VR Medical Importadora e Distribuidora de Produtos Médicos Ltda Brazil
Viscoelastic Sodium hyaluronate (3%) AMO VITRAX II (Anvisa record: 80147060068), batches affected: 012936, 012937, 013627, 015753, 016935, 016937, 018475, 018476, 018949, 020184, 023246, 023343. Vistatek Produtos Óticos S/A.; Abbott Medical Optics Inc. Brazil
ACRYLIC LENS TECNIS 1 PART MODEL ZCB00. Registro Anvisa 80147060093. Products affected: products with the following expiration dates 05/2011, 06/2011, 07/2011, 08/2011, 09/2011 and 10/2011. Vistatek Produtos Óticos S/A.; Abbott Medical Optics Inc. Brazil
KYPHK HV-R HIGH VISCOSITY RADIOPHONE BODY - Registered in Anvisa under the number 80102510396 - Lots: EL21208; EL21708; EL24408; EL24608. VR Medical Importadora e Distribuidora de Produtos Médicos Ltda Brazil
CATEGORY ANGIOGRÁFICO IMAGER II - Registered in Anvisa under the number 10341350453 - Lots - see attached list. Boston Scientific do Brasil Ltda. Brazil
CATETER GUIDER SOFTIP GUIDE - Registered in Anvisa under the number 10341350444 - Lots as listed in the appendix. Boston Scientific do Brasil Ltda. Brazil
POWERHEART AUTOMATIC EXTERNAL DEFIBRILLATOR. Models existing in Brazil that may be affected: 9300A, 9300C, 9300E and 9300P, produced between August 2003 and August 2009. ANVISA records: 10265410052 (Tecnimed Comercial Ltda) and 10312210014 (Medcorp Hospitalar Ltda). Affected serial numbers: check at www.cardiacscience.com/AED175. Cardiovascular Devices Tecnimed/Paramedics Eletromedicina Comercial Ltda e Medcorp Hospitalar Ltda; Cardiac Science Corporation Brazil
Ultra Corega ANTI-PARTICULATE SEALANT - Registered at Anvisa under the number 80141610010. GLAXO SMITH KLINE BRASIL LTDA. Brazil
NOTE: THIS MESSAGE IS BEING SENT TO UPDATE INFORMATION FROM AN ALREADY ALREADY PUBLISHED. IMPLANTABLE MARCAPASSO ENRHYTHM P1501DR MEDTRONIC. Registro Anvisa 10339190253. Check affected models at: http://portal.anvisa.gov.br/wps/wcm/connect/9af3ad80418176aeab4cfbc509124714/Produtosasafedados.pdf?MOD=AJPERES. Medtronic Comercial Ltda. Brazil
Implantable Cardioversor Defibrillator TELIGEN 100 (Anvisa Record: 10341350535; affected models: F102; E102) ;. . Cardioversor Implantable Defibrillator TELIGEN 100 Dual Camera (Anvisa Record: 10341350534; affected models: F110; F111; E110; E111); and. . Implantable Resynchronizing Defibrillator COGNIS 100 (Anvisa Record: 10341350536; affected models: P106; P107; P108; N106; N107; N108; N118; N119). Boston Scientific do Brasil Ltda.; Boston Scientific. Brazil
LEGENDAIR Pulmonary Ventilator. Anvisa Record: 80136710174. Mallinckrodt do Brasil Ltda. Brazil
Glove for Non-Surgical Procedures Model Sempermed Phoenix, brand Sempermed (latex, smooth, ambidextrous, non-sterile, with powder, sizes P and PP). Anvisa Registry: 10307890003. SEMPERMED BRASIL COM. EXTERIOR LTDA Brazil
HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER. Anvisa Record: 10068390123. All the serial numbers. Baxter Hospitalar Ltda. Brazil
MILLENNIUM Microsurgical System (Anvisa Reg: 10196150071) and STELLARIS Microcirurgical System (Anvisa Reg: 80136060123). Bausch & Lomb. Brazil
Equipment for Angiography INTEGRIS ALLURA with VELARA GENERATOR, registered in Anvisa under the number 10216710154 - Lot / Serial No. - according to the attached distribution list. http://en.wikipedia.org/w/index.php?? PHILIPS MEDICAL SYSTEMS LTDA Brazil
PRODUCTS FOR CAUTERIZATION OF COLD WAVES - ALL TYPES. N/A Brazil
80371250003 - Ductable Intervertebral Stabilization Plate in Peek ;. 80371250004 - Screw Masterteck Peek LT1 Bioteck Indústria, Comércio, Importação e Exportação de Implantes Bio-absorviveis LTDA Brazil
MAMMARY IMPLANT FILLED WITH HIGH COESIVITY GEL (Anvisa reg.: 80152300001); MENTAL IMPLANT FILLED WITH HIGH ROTATION GEL COESIVITY (reg. Anvisa: 80152300006). Poly Implants Prothese; EMI Importação e Distribuição Ltda. Brazil
KNIFE KNEE FOR TRACHEOSTOMY WITH SHILEY BALLOON (Anvisa Registry n ° 10139810076). List of affected products available at http://portal.anvisa.gov.br/wps/wcm/connect/aff6ed80422df0209b12ff01cce3dc94/Lista+de+Produtos+Afetados.pdf?MOD=AJPERES Anesthesiology Devices MALLINCKRODT DO BRASIL LTDA.; Covidien. Brazil