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No image published for this recall

Angiodynamics Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892 - safety alert

Official notice

20 Jun 2018

Last checked

20 Jun 2018

Medium riskFDA

An official FDA notice concerns Angiodynamics Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892 - safety alert. An official FDA notice concerns Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892. The notice reports an infection risk. Follow the official notice for consumer instructions. Published 2018-06-20. Lots: 5304323. Recall numbers: Z-2195-2018. Check the official notice for the complete list. Published 2018-06-20.

What to do now

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

Units affected

11

Recall number

Z-2195-2018

Official notice

2018-06-20

The hazard

An official FDA notice concerns Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892. The notice reports an infection risk. Follow the official notice for consumer instructions. Published 2018-06-20. Lots: 5304323. Recall numbers: Z-2195-2018. 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

5304323

Event Ids

80169

Recall Numbers

Z-2195-2018

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Affected products

Product 1

Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

Units affected

11

Risk / hazard

An official FDA notice concerns Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892. The notice reports an infection risk. Follow the official notice for consumer instructions. Published 2018-06-20. Lots: 5304323. Recall numbers: Z-2195-2018. 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 · NY · Glens Falls

Affected area 1

US · United States · NY · Glens Falls

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Angiodynamics. Contact: Angiodynamics Inc. (Navilyst Medical Inc.).

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-2195-2018

Event id

80169

Units affected

11

Status

terminated

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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