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Cook StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044 - safety alert

Official notice

9 May 2018

MediumFDA

An official FDA notice concerns StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2018-05-09. Recall numbers: Z-1590-2018. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

751

Recall number

Z-1590-2018

Official notice

2018-05-09

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

79731

Recall Numbers

Z-1590-2018

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Affected products

Product 1

StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044

Units affected

751

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

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Cook. Contact: Cook Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-1590-2018

Event id

79731

Units affected

751

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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