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Merit Medical PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT - safety alert

Official notice

6 May 2020

MediumFDA

An official FDA notice concerns PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2020-05-06. Recall numbers: Z-1796-2020. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,932

Recall number

Z-1796-2020

Official notice

2020-05-06

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

85292

Recall Numbers

Z-1796-2020

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Affected products

Product 1

PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT

Units affected

1,932

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 · AL

Location 2

US · United States · AR

Location 3

US · United States · AZ

Location 4

US · United States · CA

Location 5

US · United States · CO

Location 6

US · United States · DC

Location 7

US · United States · DE

Location 8

US · United States · FL

Location 9

US · United States · GA

Location 10

US · United States · IA

Location 11

US · United States · ID

Location 12

US · United States · IL

Location 13

US · United States · IN

Location 14

US · United States · KS

Location 15

US · United States · MA

Location 16

US · United States · MD

Location 17

US · United States · MI

Location 18

US · United States · MN

Location 19

US · United States · MO

Location 20

US · United States · NC

Location 21

US · United States · NH

Location 22

US · United States · NJ

Location 23

US · United States · NM

Location 24

US · United States · NV

Location 25

US · United States · NY

Location 26

US · United States · OH

Location 27

US · United States · OR

Location 28

US · United States · PA

Location 29

US · United States · SC

Location 30

US · United States · TN

Location 31

US · United States · TX

Location 32

US · United States · VA

Location 33

US · United States · WI

Affected area 1

US · United States

Affected area 2

AE · United Arab Emirates

Affected area 3

CA · Canada

Affected area 4

CH · Switzerland

Affected area 5

DE · Germany

Affected area 6

ES · Spain

Affected area 7

FR · France

Affected area 8

GB · United Kingdom

Affected area 9

HK · Hong Kong

Affected area 10

IT · Italy

Affected area 11

JP · Japan

Affected area 12

MX · Mexico

Affected area 13

PT · Portugal

Affected area 14

SG · Singapore

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-1796-2020

Event id

85292

Units affected

1,932

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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