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No image published for this recall

Medtronic Navigation Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 - safety alert

Official notice

18 Dec 2019

Last checked

18 Dec 2019

Medium riskFDA

An official FDA notice concerns Medtronic Navigation Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 - safety alert. An official FDA notice concerns Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2019-12-18. Lots: 66503918A. Recall numbers: Z-0657-2020. Check the official notice for the complete list. Published 2019-12-18.

What to do now

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

Units affected

10,448

Recall number

Z-0657-2020

Official notice

2019-12-18

The hazard

An official FDA notice concerns Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2019-12-18. Lots: 66503918A. Recall numbers: Z-0657-2020. 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

66503918A

Event Ids

84191

Recall Numbers

Z-0657-2020

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Affected products

Product 1

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

Units affected

10,448

Risk / hazard

An official FDA notice concerns Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2019-12-18. Lots: 66503918A. Recall numbers: Z-0657-2020. 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 · CO · Louisville

Affected area 1

US · United States · CO · Louisville

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic Navigation. Contact: Medtronic Navigation, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-0657-2020

Event id

84191

Units affected

10,448

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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