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Instrumentation Laboratory ROTEM ex-tem; US Part No: 503-05-US - safety alert

Official notice

18 Sept 2019

MediumFDA

An official FDA notice concerns ROTEM ex-tem; US Part No: 503-05-US. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2019-09-18. Lots: 42255901. Recall numbers: Z-2485-2019. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

364

Recall number

Z-2485-2019

Official notice

2019-09-18

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

42255901

Event Ids

83523

Recall Numbers

Z-2485-2019

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Affected products

Product 1

ROTEM ex-tem; US Part No: 503-05-US

Units affected

364

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 · IL

Location 2

US · United States · MI

Location 3

US · United States · WI

Affected area 1

US · United States

Affected area 2

AR · Argentina

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BE · Belgium

Affected area 6

CA · Canada

Affected area 7

CH · Switzerland

Affected area 8

CY · Cyprus

Affected area 9

CZ · Czech Republic

Affected area 10

DE · Germany

Affected area 11

DK · Denmark

Affected area 12

ES · Spain

Affected area 13

FR · France

Affected area 14

GB · United Kingdom

Affected area 15

HK · Hong Kong

Affected area 16

HU · Hungary

Affected area 17

IE · Ireland

Affected area 18

IL · Israel

Affected area 19

IN · India

Affected area 20

IT · Italy

Affected area 21

JO · Jordan

Affected area 22

JP · Japan

Affected area 23

KR · South Korea

Affected area 24

NL · Netherlands

Affected area 25

PL · Poland

Affected area 26

PT · Portugal

Affected area 27

RS · Serbia

Affected area 28

SE · Sweden

Affected area 29

SG · Singapore

Affected area 30

VN · Vietnam

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Instrumentation Laboratory. Contact: Instrumentation Laboratory Co..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2485-2019

Event id

83523

Units affected

364

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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