International safety notice
Bone Marrow Collection and Aspiration Kit
Brazil / Anvisa · BRA · Jul 11, 2017
Key facts
| Title | Bone Marrow Collection and Aspiration Kit |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: ONCONTROL POWERED BONE ACCESS AND BONE LESION BIOPSY SYSTEM Technical name: Bone Marrow Collection and Aspiration Kit ANVISA registration number: 80117580215 Risk class: II Modelo afetado: 9461 OnControl Coaxial Tray, 10GA x 152MM / 12GA x 197MM; 9462 OnControl Coaxial Tray, 11GA x 152MM / 13GA x 197MM; 9463 OnControl Coaxial Tray, 10GA x 102MM / 12GA x 147MM; 9464 OnControl Coaxial Tray, 11GA x 102MM / 13GA x 147MM; 9465 OnControl Coaxial Tray, 10GA x 60MM / 12GA x 105MM; 9466 OnControl Coaxial Tray, 11GA x 60MM / 13GA x 105MM Affected Serial Numbers: Affected Model: 9461 OnControl Coaxial Tray, 10GA x 152MM / 12GA x 197MM - Lots: 014615, 015399, 13686 Affected Model: 9462 OnControl Coaxial Tray, 11GA x 152MM / 13GA x 197MM - Lots: 013251, 012580S Affected Model: 9463 OnControl Coaxial Tray, 10GA x 102MM / 12GA x 147MM - Lots: 014616, 015396 Affected Model: 9464 OnControl Coaxial Tray, 11GA x 102MM / 13GA x 147MM - Lots: 14453,014618, 015269, 014025. / Affected Model: 9465 OnControl Coaxial Tray, 10GA x 60MM / 12GA x 105MM - Lots: 014321S Affected Model: 94 66 OnControl Coaxial Tray, 11GA x 60MM / 13GA x 105MM - Lot: 012685S |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES LTDA CNPJ 04967408000198 ENDEREÇO SIA TRECHO 3 LOTES 20102020 1 ANDAR ED MYRIAM BAIRRO ZONA INDUSTRIAL TELEFONE 6130128451 FABRICANTE TELEFLEX MEDICAL IDA BUSINESS AND TECHNOLOGY PARK DUBLIN ROAD ATHLONE CO WESTMEATH IRLANDA TELEFONE 6130128451 |
| Models | 014618, 13686, 015399, 014321S, 14453, 012685S, 014616, 015269, 014615, 012580S, 013251, 015396 and 2 more |
| Date | Jul 11, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 10–99 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