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Covidien EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only - safety alert

Official notice

19 Jun 2024

CriticalFDA

An official FDA notice concerns EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2024-06-19. Lots: 22K0854JZ, 22E0781JZ. Recall numbers: Z-2038-2024. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Recall number

Z-2038-2024

Official notice

2024-06-19

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.

Lots

22K0854JZ, 22E0781JZ

Event Ids

94541

Recall Numbers

Z-2038-2024

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Affected products

Product 1

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

Risk / hazard

Chemical exposure risk

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

AE · United Arab Emirates

Affected area 3

AR · Argentina

Affected area 4

AT · Austria

Affected area 5

AU · Australia

Affected area 6

BE · Belgium

Affected area 7

CA · Canada

Affected area 8

CH · Switzerland

Affected area 9

DE · Germany

Affected area 10

DK · Denmark

Affected area 11

IE · Ireland

Affected area 12

IT · Italy

Affected area 13

KW · Kuwait

Affected area 14

NO · Norway

Affected area 15

NZ · New Zealand

Affected area 16

PT · Portugal

Affected area 17

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien. Contact: Covidien, LLC.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

critical

Recall details

Recall number

Z-2038-2024

Event id

94541

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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