International safety notice
Alert 2948 (Technovigilance) Smiths Medical do Brasil Produtos Hospitalares Ltda - Safety Needle for Port-a-cath - Gripper Plus Possibility that specific batches contain clogged or blocked needles.
Brazil / Anvisa · BRA · Aug 16, 2019
Key facts
| Title | Alert 2948 (Technovigilance) Smiths Medical do Brasil Produtos Hospitalares Ltda - Safety Needle for Port-a-cath - Gripper Plus Possibility that specific batches contain clogged or blocked needles. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Safety Needle for Port-a-cath - Gripper Plus Technical Name: Needle ANVISA registration number: 80228990030 Risk Class: II Affected model: 21-2760-24; Affected batch numbers: 3770622; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SMITHS MEDICAL DO BRASIL PRODUTOS HOSPITALARES LTDA CNPJ 06019570000100 RUA GEORGE OHM 206 CONJ 5152 TORRE B SÃO PAULO SP TEL 11 33725959 EMAIL FERNANDATHOMANNSMITHSMEDICALCOM FABRICANTE DO PRODUTO SMITHS MEDICAL ASD INC 1265 GREY FOX ROAD ST PAUL MN 55112 ESTADOS UNIDOS |
| Models | 21-2762-24, 3725079, 21-2763-24, 21-2960-24, 21-2769-24, 3770653, 3653180, 3671593, 3675798, 3731181, 3666439, 3628103 and 53 more |
| Date | Aug 16, 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