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Merit Medical - safety alert

Official notice

20 Apr 2022

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 2022-04-20. Recall numbers: Z-0903-2022. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

36,445

Recall number

Z-0903-2022

Official notice

2022-04-20

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.

Event Ids

89815

Recall Numbers

Z-0903-2022

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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 · AK

Location 2

US · United States · AL

Location 3

US · United States · AR

Location 4

US · United States · AZ

Location 5

US · United States · CA

Location 6

US · United States · CO

Location 7

US · United States · DC

Location 8

US · United States · DE

Location 9

US · United States · FL

Location 10

US · United States · GA

Location 11

US · United States · HI

Location 12

US · United States · IA

Location 13

US · United States · ID

Location 14

US · United States · IL

Location 15

US · United States · IN

Location 16

US · United States · KS

Location 17

US · United States · KY

Location 18

US · United States · LA

Location 19

US · United States · MA

Location 20

US · United States · MD

Location 21

US · United States · ME

Location 22

US · United States · MI

Location 23

US · United States · MN

Location 24

US · United States · MO

Location 25

US · United States · MS

Location 26

US · United States · MT

Location 27

US · United States · NC

Location 28

US · United States · ND

Location 29

US · United States · NE

Location 30

US · United States · NH

Location 31

US · United States · NJ

Location 32

US · United States · NM

Location 33

US · United States · NV

Location 34

US · United States · NY

Location 35

US · United States · OH

Location 36

US · United States · OK

Location 37

US · United States · OR

Location 38

US · United States · PA

Location 39

US · United States · RI

Location 40

US · United States · SC

Location 41

US · United States · SD

Location 42

US · United States · TN

Location 43

US · United States · TX

Location 44

US · United States · UT

Location 45

US · United States · VA

Location 46

US · United States · VT

Location 47

US · United States · WA

Location 48

US · United States · WI

Location 49

US · United States · WV

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

BE · Belgium

Affected area 4

CA · Canada

Affected area 5

CH · Switzerland

Affected area 6

CO · Colombia

Affected area 7

CZ · Czech Republic

Affected area 8

DE · Germany

Affected area 9

ES · Spain

Affected area 10

FR · France

Affected area 11

GB · United Kingdom

Affected area 12

GR · Greece

Affected area 13

IE · Ireland

Affected area 14

IT · Italy

Affected area 15

JP · Japan

Affected area 16

KR · South Korea

Affected area 17

LU · Luxembourg

Affected area 18

NL · Netherlands

Affected area 19

PL · Poland

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-0903-2022

Event id

89815

Units affected

36,445

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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