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Merit Medical - safety alert

Official notice

4 Aug 2021

MediumFDA

An official FDA notice concerns Merit Medical. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2021-08-04. Lots: H1862928, H1896262, H1896263, H18962650. Recall numbers: Z-2166-2021. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

7,211

Recall number

Z-2166-2021

Official notice

2021-08-04

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

H1862928, H1896262, H1896263, H18962650

Event Ids

88191

Recall Numbers

Z-2166-2021

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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

AE · United Arab Emirates

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

CH · Switzerland

Affected area 6

CN · China

Affected area 7

DE · Germany

Affected area 8

DK · Denmark

Affected area 9

ES · Spain

Affected area 10

FI · Finland

Affected area 11

FR · France

Affected area 12

GB · United Kingdom

Affected area 13

IL · Israel

Affected area 14

JP · Japan

Affected area 15

NL · Netherlands

Affected area 16

NO · Norway

Affected area 17

NZ · New Zealand

Affected area 18

SA · Saudi Arabia

Affected area 19

SE · Sweden

Affected area 20

SK · Slovakia

Affected area 21

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-2166-2021

Event id

88191

Units affected

7,211

Status

terminated

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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