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Merit Medical - safety alert

Official notice

3 Jul 2024

MediumFDA

An official FDA notice concerns Merit Medical. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-07-03. Lots: added. Recall numbers: Z-2218-2024. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

52,410

Recall number

Z-2218-2024

Official notice

2024-07-03

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

added

Event Ids

94684

Recall Numbers

Z-2218-2024

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AR · Argentina

Affected area 3

BR · Brazil

Affected area 4

CA · Canada

Affected area 5

CL · Chile

Affected area 6

CO · Colombia

Affected area 7

CR · Costa Rica

Affected area 8

DO · Dominican Republic

Affected area 9

HK · Hong Kong

Affected area 10

KR · South Korea

Affected area 11

MX · Mexico

Affected area 12

NZ · New Zealand

Affected area 13

PE · Peru

Affected area 14

UY · Uruguay

Affected area 15

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Merit Medical. Contact: Merit Medical Systems, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2218-2024

Event id

94684

Units affected

52,410

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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