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Advance Medical Designs Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 - safety alert

Official notice

20 Sept 2023

Last checked

20 Sept 2023

Medium riskFDA

An official FDA notice concerns Advance Medical Designs Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 - safety alert. An official FDA notice concerns Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-09-20. Lots: 30479C3299, 30394C3279. Recall numbers: Z-2534-2023. Check the official notice for the complete list. Published 2023-09-20.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

26,900

Recall number

Z-2534-2023

Official notice

2023-09-20

The hazard

An official FDA notice concerns Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-09-20. Lots: 30479C3299, 30394C3279. Recall numbers: Z-2534-2023. Check the official notice for the complete list.

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

30479C3299, 30394C3279

Event Ids

92735

Recall Numbers

Z-2534-2023

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Affected products

Product 1

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

Units affected

26,900

Risk / hazard

An official FDA notice concerns Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-09-20. Lots: 30479C3299, 30394C3279. Recall numbers: Z-2534-2023. Check the official notice for the complete list.

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 · GA · Marietta

Affected area 1

US · United States · GA · Marietta

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Advance Medical Designs. Contact: Advance Medical Designs, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-2534-2023

Event id

92735

Units affected

26,900

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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