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Bard mission disposable core biopsy instrument kit

Official notice

28 Nov 2023

Last checked

28 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Bard mission disposable core biopsy instrument kit. BD continues to receive complaints for the product regarding mismatch between the coaxial and the needle in mission kit devices. Based on the event reported, the internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue. Recall start date: November 8, 2023 Published 2023-11-28.

What to do now

Review notice/ share with users, identify/destroy remaining inventory, complete/return response form.

Recall number

74660

Official notice

2023-11-28

The hazard

BD continues to receive complaints for the product regarding mismatch between the coaxial and the needle in mission kit devices. Based on the event reported, the internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue. Recall start date: November 8, 2023

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.

Recall Numbers

74660

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Affected products

Product 1

Affected products - Bard Mission Disposable Core Biopsy Instrument Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 1820MSK 1416MSK 2020MSK 2016MSK 1410MSK 1816MSK 2010MSK 1610MSK 1616MSK 1810MSK 1825MSK

Risk / hazard

BD continues to receive complaints for the product regarding mismatch between the coaxial and the needle in mission kit devices. Based on the event reported, the internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue. Recall start date: November 8, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Bard Peripheral Vascular, Bard Mission Disposable Core Biopsy Instrument Kit.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74660

Classification

Type 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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