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MINI - safety alert

Official notice

6 Apr 2022

CriticalFDA

An official FDA notice concerns MINI. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2022-04-06. Recall numbers: Z-0855-2022. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

175,801

Recall number

Z-0855-2022

Official notice

2022-04-06

The hazard

Chemical exposure risk

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

89653

Recall Numbers

Z-0855-2022

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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 · CT

Location 8

US · United States · DC

Location 9

US · United States · DE

Location 10

US · United States · FL

Location 11

US · United States · GA

Location 12

US · United States · HI

Location 13

US · United States · IA

Location 14

US · United States · ID

Location 15

US · United States · IL

Location 16

US · United States · IN

Location 17

US · United States · KS

Location 18

US · United States · KY

Location 19

US · United States · LA

Location 20

US · United States · MA

Location 21

US · United States · MD

Location 22

US · United States · ME

Location 23

US · United States · MI

Location 24

US · United States · MN

Location 25

US · United States · MO

Location 26

US · United States · MS

Location 27

US · United States · MT

Location 28

US · United States · NC

Location 29

US · United States · ND

Location 30

US · United States · NE

Location 31

US · United States · NH

Location 32

US · United States · NJ

Location 33

US · United States · NM

Location 34

US · United States · NV

Location 35

US · United States · NY

Location 36

US · United States · OH

Location 37

US · United States · OK

Location 38

US · United States · OR

Location 39

US · United States · PA

Location 40

US · United States · RI

Location 41

US · United States · SC

Location 42

US · United States · SD

Location 43

US · United States · TN

Location 44

US · United States · TX

Location 45

US · United States · UT

Location 46

US · United States · VA

Location 47

US · United States · VT

Location 48

US · United States · WA

Location 49

US · United States · WI

Location 50

US · United States · WV

Location 51

US · United States · WY

Affected area 1

US · United States

Affected area 2

AU · Australia

Affected area 3

JP · Japan

Affected area 4

KR · South Korea

Affected area 5

NZ · New Zealand

Affected area 6

TW · Taiwan

Company & contacts

Manufacturer

Not provided

Phone

Not provided

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

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

critical

Recall details

Recall number

Z-0855-2022

Event id

89653

Units affected

175,801

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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