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MINI - safety alert

Official notice

14 Feb 2024

MediumFDA

An official FDA notice concerns MINI. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-02-14. Recall numbers: Z-1005-2024. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

114,758

Recall number

Z-1005-2024

Official notice

2024-02-14

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

93675

Recall Numbers

Z-1005-2024

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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

AT · Austria

Affected area 3

BE · Belgium

Affected area 4

CH · Switzerland

Affected area 5

CZ · Czech Republic

Affected area 6

DE · Germany

Affected area 7

DK · Denmark

Affected area 8

ES · Spain

Affected area 9

FI · Finland

Affected area 10

FR · France

Affected area 11

GB · United Kingdom

Affected area 12

GR · Greece

Affected area 13

IE · Ireland

Affected area 14

IL · Israel

Affected area 15

IN · India

Affected area 16

IS · Iceland

Affected area 17

IT · Italy

Affected area 18

KW · Kuwait

Affected area 19

LI · Liechtenstein

Affected area 20

LU · Luxembourg

Affected area 21

NL · Netherlands

Affected area 22

NO · Norway

Affected area 23

PL · Poland

Affected area 24

PT · Portugal

Affected area 25

RO · Romania

Affected area 26

SA · Saudi Arabia

Affected area 27

SE · Sweden

Affected area 28

SI · Slovenia

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: MINI, Medtronic Minimed. Contact: Medtronic MiniMed, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-1005-2024

Event id

93675

Units affected

114,758

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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