International safety notice
Alert 2495 (Technosurveillance) - Medstar - SUROS - TriMark Location Identification Device Product manufacturing plant is not regularized with ANVISA in terms of CBPF.
Brazil / Anvisa · BRA · Feb 27, 2018
Key facts
| Title | Alert 2495 (Technosurveillance) - Medstar - SUROS - TriMark Location Identification Device Product manufacturing plant is not regularized with ANVISA in terms of CBPF. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: SUROS TriMark Location Identification Device Technical name: SUROS, TRIMARK SITE IDENTIFICATION APPARATUS ANVISA registration number: 80047300529 Risk class: III Modelo afetado: TRIMARK TD 13-09; TRIMARK TD 13-12; TRIMARK TD 13-MR; TRIMARK TD 36-09; TRIMARK TD 36-12. Affected serial number: TRIMARK TD 1309 lots 17K05RF TRIMARK TD 1312 lotes: 16L08RN, 16K24RM, 17A13RL, 17C10RC, 17D17RA, 17H07RA, 17J08RH, TRIMARK TD 13MR lotes: 17C02RF, 17C24RB,17D17RB TRIMARK TD 3609 lotes: 16K20RA, 16K25RK, 17A10RB, 17B02RF, 17C10RD,17G31RA, 17D24RD, 17F19R, 17G05RA, 17G31RA, 17H14RA, 17K05RB, 17L01RB |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA CNPJ 03580620000135 RUA VALÊNCIO SOARES RODRIGUES 89 SALA 1 CENTRO CEP 06730000 VARGEM GRANDE SP FABRICANTE HOLOGIC INC 250 CAMPUS DRIVE MARLBOROUGH EUA EMAIL HOLOGICQARAWORKSCOM |
| Models | 16L08RN, 17D24RD, 17C02RF, 17H07RA, 17H14RA, 17G05RA, 16K24RM, 17K05RB, 13-MR, 17D17RB, 17K05RF, 17B02RF and 17 more |
| Date | Feb 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1