List view Cards view
Name Date Date initiated Country Source
Safety Alert for Commercial Name: Intra - Aortic Balloon Pump. Technical Name: Intra-Aortic Balloon Pump System. ANVISA registration number: 10390690062. Risk class: III. Affected model: CS100 intra-aortic balloon pump; Intra-aortic balloon pump CS300. Affected serial numbers: All units distributed between March 24, 2003 and December 11, 2013. 2017-08-15 Brazil ANVISA
Safety Alert for Commercial name: cobas c 501 module and cobas c 502 module. Technical name: Physiological Fluid Analyzer. ANVISA registration number: 10287410597 and 10287410878. Risk class: I and II. Affected Model:. Serial numbers affected: 4745914001, 5964067001 2017-08-10 Brazil ANVISA
Safety Alert for Trade name: Chemical Efficiency Checker And Ii Vitros *. Technical Name: Combined Parameters In Same Product - Class II. ANVISA registration number: 10132590232. Class of risk: II. Affected model: 12 x 3 ml of the level I lyophilized checker; 12 x 5 ml diluent for level II verifier; 12 x 3 ml of the level II lyophilized checker; 12 x 5 ml diluent for Level I verifier. Serial numbers affected: SKU: 8231474 | Lot: K4852 2017-08-08 Brazil ANVISA
Safety Alert for Trade name: MOSAIQ. Technical Name: Software de Planej. of Trat. by Radiacao. ANVISA registration number: 80569320004. Class of risk: III. Affected template: All versions. Affected serial numbers: Linear Accelerators with RATM license 2017-08-07 Brazil ANVISA
Safety Alert for Trade name: Vygon PVC Umbilical Catheter. Technical Name: Catheter. ANVISA registration number: 10234400082. Risk class: IV. Model affected: 270.03. Serial numbers affected: 01 - 151216FR; 02 - 060117FR 2017-08-09 Brazil ANVISA
Safety Alert for Trade name: Dry Vitros Reagent * For Digoxin DGXN. Technical Name: Digoxin. ANVISA registration number: 10132590249. Risk class: II. Affected model: 5 cartridges with 18 slides. Serial numbers affected: SKU: 8343386 | Lot: 1913-0242-9236 2017-08-08 Brazil ANVISA
Safety Alert for Trade name: TrueBeam, VitalBeam and Edge. Technical Name :. ANVISA registration number: 10405410022. Risk class: III. Model Affected: N / A. Serial numbers affected: H192524, H191578, H191700, H192523, H191762, H191581, H191559, H192534 2017-08-15 Brazil ANVISA
Safety Alert for Trade name: Catheter introducer with and without Valve. Technical name: Introducers. ANVISA registration number: 10175060025. Risk class: II. Model Affected: 05039540 - Catheter Introducer-40cm / 05039560 - Catheter Introducer-60cm. Serial numbers affected: AUTO089787, AUTO089747 2017-08-08 Brazil ANVISA
Safety Alert for Trade name: Immuno-LATEX ASLO. Technical Name: Streptolysin O - ASLO. ANVISA registration number: 10310030069. Risk class: II. Model Affected: COD .: 21060-L / 21100-L. Serial numbers affected: 17C064 / 17C066 / 17D152 2017-08-08 Brazil ANVISA
Safety Alert for Trade name: Immuno-LATEX ASLO 2.5ML. Technical Name: ESTREPTOLISIN O - ASLO. ANVISA registration number: 10310030090. Class of risk: II. Model Affected: COD .: 21000-L. Affected Batch Numbers: Batch Affected: 17C065 / 17C067 / 17D151 / 17D153 2017-07-08 Brazil ANVISA
Safety Alert for Trade name: Control Tip Microline. Technical name: Laparoscopic instruments. ANVISA registration number: 80312270010. Risk class: I. Model: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331, 3341,3351,3361,3371,3381 , 3401, 3411, 3421, 3431. . Series numbers :. . MODEL 3201 - Lots: 00110853,00112170,00113032,00115835, 00111514. MODEL 3221 - Lots: 00110759, 00112307, 00112786, 00113260, 00116751, 00118024, 00133063, 00113472, 00118164. MODEL 3231 - Lots: 00110481, 00111591, 00112869, 00114060 00112971, 00117191, 00117191, 00132930, 00111234. MODEL 3241 - Lots: 00110976, 00113013, 00116418, 00118336, 00111288. MODEL 3251 - Lots: 00110760, 00111197, 00112828, 00115999, 00116403. MODEL 3261 - Lots: 00111367, 00111743, 00111955, 00112820, 00113462, 00116081, 00116498, 00117981, 00113640. MODEL 3271 - Lots: 00110537, 00111557, 00112749, 00116028, 00117360 .. MODEL 3281 - Batch: 00115602 .. MODEL 3291 - Lots: 00111360, 00111869, 00113145, 00116325, 00117975 , 00113464. MODEL 3301 - Lots: 00110196, 00111583, 00112748, 00115010, 00116724 .. MODEL 3311 - Batch: 00114069. MODEL 3321 - Lots: 00111761, 00116666, 00130302, 00132678 .. MODEL 3331 - Lots: 00111236, 00111510, 00112530 , 00114067, 00116715, 00130161, 00113357, 00117979. MODEL 3341 - Lot s: 00111516, 00114068, 00117747, 00130533, 00130304 .. MODEL 3351 - Lots: 00111121, 00112308, 00112947, 00116052, 00116796, 00117792, 00113358. MODEL 3361 - Batch: 00111237, 00116642, 00129918, 00133056 .. MODEL 3381 - Lots : 00114828; 00130320 .. MODEL 3421 - Lots: 00101955, 00104270 .. MODEL 3431 - Lots: 00106637, 00127466. This product was added to our catalog on Monday 01 December, 2008. 2017-08-01 Brazil ANVISA
Safety Alert for Commercial Name: Hemostatic Clip. Technical Name: Clamp. ANVISA registration number: 10175069002. Class of risk: II. Affected Model: 479201: Introducing Cannula: 20 G x 9 cm; Length of the thread: 20 cm; Distance: 11.3 cm. Affected serial numbers: Of all lots involved, only one was imported into Brazil: REZL0066 2017-04-07 Brazil ANVISA
Safety Alert for Commercial Name: Hemostatic Clip. Technical Name: Clamp. ANVISA registration number: 10175069002. Class of risk: II. Affected Model: 01019502 - Hemostatic Clip. Serial numbers affected: AUTO089768, AUTO089789 2017-08-03 Brazil ANVISA
Safety Alert for Trade name: cobas and 602 modules, cobas and 601 and E170. Technical Name: Physiological Fluid Analyzer. ANVISA registration number: 10287410597; 10287410878; 10287410671; Risk class: I and II. Affected Model:. Serial numbers affected: 4745922001, 5990378001, 4998642001, 3617505001 2017-07-24 Brazil ANVISA
Safety Alert for Commercial Name: Disposable Pressure Transducer TPD-48120 HOSP TRADE. Technical Name: Transducer. ANVISA registration number: 80275279004. Class of risk: III. Affected Model: TPD-48120 HOSP TRADE. Serial numbers affected: 314322043, 314147218 2017-08-03 Brazil ANVISA
Safety Alert for Trade name: AEO - Latex. Technical name: AEO - Latex. ANVISA registration number: 80022230177. Class of risk: II. Affected model: In vitro diagnostic kit. Serial numbers affected :. Cat. 541 - 7033 - manufactured (04/06/17 - validity: 01/31/19) = 231 kit's. Cat. 541L-7053 - manufactured (05/22/17 - validity: 05/30/19) = 450 kit's. Cat. 541 - 7062 - manufactured (06/16/17 - validity: 01/31/19) = 150 kit's 2017-07-27 Brazil ANVISA
Safety Alert for Trade name: CIOS ALPHA Surgical Arc. Technical Name: Surgical Arc. ANVISA registration number: 10345162008. Risk class: III. Model affected: CIOS ALPHA. Serial numbers affected: 12021 2017-07-28 Brazil ANVISA
Safety Alert for Trade name: Vanguard PS Knee System. Technical Name: Total Knee Prostheses. ANVISA registration number: 80044680074. Risk class: III. Model affected: 00 000 000 1831 28. Serial numbers affected: J3798251; J3847223 2017-08-01 Brazil ANVISA
Safety Alert for Trade name: Technical name: Registration number. . Ammonia Reagents (AMM); Ammonia 10345161867. . Transaminase Glutamic P-Transaminase 10345160498. Rubic (TGP OR ALT); Pyruvic Glutamic. (Tgp or Alt). . . ADVIA CHEMISTRY Alanine Transaminase 10345161103. Aminotransferase Pyruvic Glutamic Concentrate. ted Reagents (ALT_C); (TGP or ALT). . . Dimension Amonia Flex; Ammonia 10345161934. . Alanine Amino Transaminase Reagent 10345161852. transferase ALTI (TGP) Tell me Pyruvic Glutamic. nsion; (TGP or ALT). . . . Aspartate Amino Transaminase Reagent 10345161537. transferase (AST) - Dimension; Glutamic. (TGP or ALT). . . Glucose Reagent Glucose Glucose 10345161260. (Gluc) Dimension ;. . . Dimension MBI Flex; Isoenzyme Activity 10345161715. Creatinine kinase. . Thyroxine Reagent (T4) Thyroxine (T4) 10345161355. Size. . Risk class: II. . Affected Model:. . Serial numbers affected: N / A. 2017-07-21 Brazil ANVISA
Safety Alert for Trade name: HEMOSIL PLASMA DEFICIENT IN FACTOR XII 10 X 1 mL - 10 x 1 mL. Technical Name: Deficient Lasma in Coagulation Factors. ANVISA registration number: 80003610279. Risk class: II. Model Affected: N / A. Serial numbers affected: N958653 (06 units), N261273 (42 units) 2017-07-24 Brazil ANVISA
Safety Alert for Trade name: Catheter Balloon Euphora. Technical Name: Catheters. ANVISA registration number: 10339190628. Class of risk: IV. affected model EUP1506X, EUP2015X, EUP22520X, EUP2530X, EUP3010X, EUP32512X, EUP3520X, EUP37525X, EUP1510X, EUP2020X, EUP22525X, EUP27506X, EUP3012X, EUP32515X, EUP3525X, EUP4006X, EUP1512X, EUP2025X, EUP2506X, EUP27510X, EUP3015X, EUP32520X, EUP3530X, EUP4010X , EUP1515X, EUP2030X, EUP2510X, EUP27512X, EUP3020X, EUP32525X, EUP37506X, EUP4012X, EUP1520X, EUP22506X, EUP2512X, EUP27515X, EUP3025X, EUP3506X, EUP37510X, EUP4015X, EUP2006X, EUP22510X, EUP2515X, EUP27520X, EUP3030X, EUP3510X, EUP37512X, EUP4020X, EUP2010X , EUP4020X, EUP2010X, EUP22512X, EUP2520X, EUP27525X, EUP32506X, EUP3512X, EUP37515X, EUP4025X, EUP2012X EUP22515X EUP2525X, EUP3006X, EUP32510X, EUP3515X, EUP37520X, EUP4030X, SLC1506X, SLC2015X, SLC22520X, SLC2530X, SLC3015X, SLC3512X, SLC4012X, SLC1510X, SLC2020X , SLC22525X, SLC2205XX, SLC2205XX, SLC2505XX, SLC2205XX, SLC2205XX, SLC2205XX, SLC2205XX, SLC2205XX, SLC2205XX, SLC2205XX, SLC2205XX , SLC2512X, SLC27525X, SLC32512X, SLC37512X, SLC4030X, SLC2006X, SLC22510X, SLC2515X, SLC3006X, SLC32515X, SLC37515X, SLC2010X, SLC22512X, SLC2520X, SLC3010X, SLC3506X, SLC37520X, SLC2012X, SLC22515X, SLC2525X, SLC3012X, SLC3510X, .. Number SLC4010X series affected: 212553130 to 213283557 2017-07-13 Brazil ANVISA
Safety Alert for Trade name: Efficia Vital Signs Monitor. Technical Name: Vital Signs Monitor. ANVISA registration number: 10216710305. Risk class: III. Model affected: CM120, CM150. Serial numbers affected: CM120: CN44701077 to CN62614750. CM150: CN50401316 to CN62609331 2017-07-21 Brazil ANVISA
Safety Alert for Trade name: Sunchrony-Cello Series Hydrocephalus Valve. Technical name: Valve for Hydrocephalus. ANVISA registration number: 10175060021. Risk class: IV. Affected model: Dulto Low, Adult Adult, Adult High, Pediatric Low, Pediatric Average, Neonatal Average, Neonatal Low. Affected serial numbers: AUTO089833, AUTO089753, AUTO089691, AUTO089689, AUTO089789, AUTO089748, AUTO089839, AUTO089839, AUTO089838, AUTO089485, AUTO089521, AUTO089571, AUTO089601, AUTO089633, AUTO089693, AUTO089693, AUTO089834, AUTO089844, AUTO089692, AUTO089755. 2017-07-21 Brazil ANVISA
Safety Alert for Commercial name: LCR Ventura External Drainage Catheter. Technical Name: Drainage Catheter. ANVISA registration number: 10175060016. Risk class: IV. Model Affected: 9720 - LCR 600A - External Drainage Catheter LCR - Adult Model; 9721 - LCR 600N - External Drainage Catheter LCR - Neonatal Model. Batch numbers affected: AUTO089700, AUTO089767, AUTO089783, AUTO089826, AUTO089792 2017-07-21 Brazil ANVISA
Safety Alert for Commercial name: Cobas e 411 and Elecsys 2010 analyzer. Technical name: Biochemical Analyzer. ANVISA registration number: 10287410608. Risk class: I. Model affected: N / A. Serial numbers affected: Not applicable. 2017-07-20 Brazil ANVISA