International safety notice
Alert 2868 (Technovigilance) Stryker do Brasil LTDA Equipment for Insufflators Recall of specific models due to withdrawal of Anvisa registration 80005430169.
Brazil / Anvisa · BRA · May 3, 2019
Key facts
| Title | Alert 2868 (Technovigilance) Stryker do Brasil LTDA Equipment for Insufflators Recall of specific models due to withdrawal of Anvisa registration 80005430169. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Equipment for Insufflators Technical Name: Equipment ANVISA registration number: 80005430169 Risk Class: II Affected model: 0620-040-690 - Pneumosure Heated RTP Inflator Tube; Affected serial numbers: All sold from 2016-2019 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO STRYKER DO BRASIL LTDA CNPJ 02966317000102 RUA URUSSUÍ 300 8º ANDAR SÃO PAULO SP TEL 11 51892550 EMAIL QUALIDADESTRYKERCOM FABRICANTE DO PRODUTO STRYKER ENDOSCOPY WOM WORLD OF MEDICINE AG 325 CORPORATE DRIVE MAHWAH NJ 07430 USA SALZUFER 8 10587 BERLIN GERMANY ESTADOS UNIDOS DA AMÉRICA ALEMANHA |
| Models | 0502200000A, 0620-040-680, 0620-040-690, 0620-040-660, 2016-2019, 80005430169 |
| Date | May 3, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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