Bard Peripheral Vascular Inc: Mission Core Biopsy Instrument Kits Recalled for Fitting and Access Issues

Agency Publication Date: January 5, 2024

Summary

Approximately 1,243,937 Bard Mission Disposable Core Biopsy Instrument Kits are being recalled because the biopsy needle may not fit properly into the internal diameter of the kit's tube (cannula). This defect occurs because the tube may be sized incorrectly or exceed the length stated on the product label. If the needle does not fit, doctors may be unable to reach the target tissue, which can result in tissue injury, prolonged surgical time, or the need for repeat procedures.

Risk

The mismatch in diameter or length between the biopsy needle and the cannula prevents proper surgical access, which can cause direct tissue injury or lead to complications from extended anesthesia and repeated medical procedures.

What You Should Do

Locate the product packaging for your Mission Kit and identify the REF number, UDI-DI, and Lot number located on the label.
Check your kit against the extensive list of affected lot numbers, such as 1410MSK (Lot 0001418630), 1610MSK (Lot 0001390419), 1810MSK (Lot 0001390415), and 2010MSK (Lot 0001390416), with expiration dates ranging from 2023 through 2025.
Immediately stop using any kits identified as part of this recall and quarantine them to ensure they are not used in medical procedures.
Contact your healthcare provider or Bard Peripheral Vascular Inc at 1-888-463-6332 for specific instructions regarding the return or replacement of these medical devices.
Healthcare professionals should follow any specific instructions provided in the notification letter sent by the firm on November 8, 2023.
For additional questions or to report a related injury, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Bard Mission Disposable Core Biopsy Instrument Kit 14G x 10CM

Model / REF:

1410MSK

UPC Codes:

00801741142543

Lot Numbers:

0001418630 (Exp 05/28/24)

0001429851 (Exp 07/28/24)

0001433778 (Exp 08/28/24)

0001441794 (Exp 10/28/24)

0001443076 (Exp 10/28/24)

0001446454 (Exp 11/28/24)

0001451131 (Exp 01/28/25)

0001452840 (Exp 01/28/25)

0001463142 (Exp 03/28/25)

0001468867 (Exp 04/28/25)

0001475757 (Exp 06/28/25)

0001481508 (Exp 07/28/25)

0001485193 (Exp 08/28/25)

0001487094 (Exp 08/28/25)

0001488512 (Exp 08/28/25)

0001491080 (Exp 09/28/25)

0001491583 (Exp 09/28/25)

0001498859 (Exp 11/28/25)

0001502349 (Exp 12/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 14G x 16CM

Model / REF:

1416MSK

UPC Codes:

00801741142550

Lot Numbers:

0001402196 (Exp 01/28/24)

0001423061 (Exp 06/28/24)

0001430525 (Exp 07/28/24)

0001434059 (Exp 08/28/24)

0001435619 (Exp 09/28/24)

0001452376 (Exp 01/28/25)

0001458437 (Exp 02/28/25)

0001464693 (Exp 03/28/25)

0001464694 (Exp 03/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 16G x 10CM

Model / REF:

1610MSK

UPC Codes:

00801741142567

Lot Numbers:

0001390419 (Exp 10/28/23)

0001392740 (Exp 10/28/23)

0001402197 (Exp 01/28/24)

0001415815 (Exp 04/28/24)

0001418632 (Exp 05/28/24)

0001426735 (Exp 06/28/24)

0001426839 (Exp 07/28/24)

0001430408 (Exp 07/28/24)

0001430528 (Exp 07/28/24)

0001433779 (Exp 08/28/24)

0001468480 (Exp 04/28/25)

0001468479 (Exp 04/28/25)

0001474221 (Exp 05/28/25)

0001478981 (Exp 06/28/25)

0001481036 (Exp 07/28/25)

0001481035 (Exp 07/28/25)

0001480804 (Exp 07/28/25)

0001480805 (Exp 07/28/25)

0001485185 (Exp 08/28/25)

0001487093 (Exp 08/28/25)

0001486540 (Exp 08/28/25)

0001491078 (Exp 09/28/25)

0001502344 (Exp 12/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 16G x 16CM

Model / REF:

1616MSK

UPC Codes:

00801741142574

Lot Numbers:

0001410073 (Exp 02/28/24)

0001418633 (Exp 05/28/24)

0001429719 (Exp 07/28/24)

0001432764 (Exp 08/28/24)

0001441990 (Exp 10/28/24)

0001445629 (Exp 11/28/24)

0001451613 (Exp 01/28/25)

0001468728 (Exp 04/28/25)

0001474220 (Exp 05/28/25)

0001474506 (Exp 05/28/25)

0001476311 (Exp 06/28/25)

0001480541 (Exp 07/28/25)

0001480542 (Exp 07/28/25)

0001498110 (Exp 11/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 18G x 10CM

Model / REF:

1810MSK

UPC Codes:

00801741097058

Lot Numbers:

0001390415 (Exp 10/28/23)

0001398597 (Exp 12/28/23)

0001402163 (Exp 01/28/24)

0001411232 (Exp 03/28/24)

0001423157 (Exp 06/28/24)

0001427153 (Exp 07/28/24)

0001439097 (Exp 10/28/24)

0001450208 (Exp 12/28/24)

0001465424 (Exp 04/28/25)

0001481263 (Exp 07/28/25)

0001501269 (Exp 12/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 20G x 10CM

Model / REF:

2010MSK

UPC Codes:

00801741097089

Lot Numbers:

0001390416 (Exp 10/28/23)

0001402093 (Exp 01/28/24)

0001414353 (Exp 03/28/24)

0001418626 (Exp 05/28/24)

0001432741 (Exp 08/28/24)

0001445947 (Exp 11/28/24)

0001448749 (Exp 12/28/24)

0001456597 (Exp 02/28/25)

0001461729 (Exp 03/28/25)

0001479643 (Exp 06/28/25)

0001488082 (Exp 08/28/25)

0001490705 (Exp 09/28/25)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93578

Status: Active

Manufacturer: Bard Peripheral Vascular Inc

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 1,243,937

Distributed To: Puerto Rico, Illinois, Massachusetts, Georgia, Kentucky, California, Texas, Pennsylvania, Iowa, Minnesota, New Hampshire, Maryland, Florida, Idaho, Indiana, Alabama, Virginia, Colorado, Wisconsin, New York, Nevada, Oklahoma, Ohio, Washington, Michigan, Mississippi, Arizona, Hawaii, South Dakota, New Jersey, Nebraska, Montana, North Carolina, District of Columbia, Connecticut, Wyoming, Utah, Tennessee, Louisiana, New Mexico, South Carolina, Vermont, Missouri, Maine, Arkansas, Oregon, Kansas, Rhode Island, Alaska, West Virginia, Delaware, North Dakota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate the product packaging for your Mission Kit and identify the REF number, UDI-DI, and Lot number located on the label.

Check your kit against the extensive list of affected lot numbers, such as 1410MSK (Lot 0001418630), 1610MSK (Lot 0001390419), 1810MSK (Lot 0001390415), and 2010MSK (Lot 0001390416), with expiration dates ranging from 2023 through 2025.

Immediately stop using any kits identified as part of this recall and quarantine them to ensure they are not used in medical procedures.

Contact your healthcare provider or Bard Peripheral Vascular Inc at 1-888-463-6332 for specific instructions regarding the return or replacement of these medical devices.

Healthcare professionals should follow any specific instructions provided in the notification letter sent by the firm on November 8, 2023.

For additional questions or to report a related injury, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Bard Mission Disposable Core Biopsy Instrument Kit 14G x 10CM

Model / REF:

1410MSK

UPC Codes:

00801741142543

Lot Numbers:

0001418630 (Exp 05/28/24)

0001429851 (Exp 07/28/24)

0001433778 (Exp 08/28/24)

0001441794 (Exp 10/28/24)

0001443076 (Exp 10/28/24)

0001446454 (Exp 11/28/24)

0001451131 (Exp 01/28/25)

0001452840 (Exp 01/28/25)

0001463142 (Exp 03/28/25)

0001468867 (Exp 04/28/25)

0001475757 (Exp 06/28/25)

0001481508 (Exp 07/28/25)

0001485193 (Exp 08/28/25)

0001487094 (Exp 08/28/25)

0001488512 (Exp 08/28/25)

0001491080 (Exp 09/28/25)

0001491583 (Exp 09/28/25)

0001498859 (Exp 11/28/25)

0001502349 (Exp 12/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 14G x 16CM

Model / REF:

1416MSK

UPC Codes:

00801741142550

Lot Numbers:

0001402196 (Exp 01/28/24)

0001423061 (Exp 06/28/24)

0001430525 (Exp 07/28/24)

0001434059 (Exp 08/28/24)

0001435619 (Exp 09/28/24)

0001452376 (Exp 01/28/25)

0001458437 (Exp 02/28/25)

0001464693 (Exp 03/28/25)

0001464694 (Exp 03/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 16G x 10CM

Model / REF:

1610MSK

UPC Codes:

00801741142567

Lot Numbers:

0001390419 (Exp 10/28/23)

0001392740 (Exp 10/28/23)

0001402197 (Exp 01/28/24)

0001415815 (Exp 04/28/24)

0001418632 (Exp 05/28/24)

0001426735 (Exp 06/28/24)

0001426839 (Exp 07/28/24)

0001430408 (Exp 07/28/24)

0001430528 (Exp 07/28/24)

0001433779 (Exp 08/28/24)

0001468480 (Exp 04/28/25)

0001468479 (Exp 04/28/25)

0001474221 (Exp 05/28/25)

0001478981 (Exp 06/28/25)

0001481036 (Exp 07/28/25)

0001481035 (Exp 07/28/25)

0001480804 (Exp 07/28/25)

0001480805 (Exp 07/28/25)

0001485185 (Exp 08/28/25)

0001487093 (Exp 08/28/25)

0001486540 (Exp 08/28/25)

0001491078 (Exp 09/28/25)

0001502344 (Exp 12/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 16G x 16CM

Model / REF:

1616MSK

UPC Codes:

00801741142574

Lot Numbers:

0001410073 (Exp 02/28/24)

0001418633 (Exp 05/28/24)

0001429719 (Exp 07/28/24)

0001432764 (Exp 08/28/24)

0001441990 (Exp 10/28/24)

0001445629 (Exp 11/28/24)

0001451613 (Exp 01/28/25)

0001468728 (Exp 04/28/25)

0001474220 (Exp 05/28/25)

0001474506 (Exp 05/28/25)

0001476311 (Exp 06/28/25)

0001480541 (Exp 07/28/25)

0001480542 (Exp 07/28/25)

0001498110 (Exp 11/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 18G x 10CM

Model / REF:

1810MSK

UPC Codes:

00801741097058

Lot Numbers:

0001390415 (Exp 10/28/23)

0001398597 (Exp 12/28/23)

0001402163 (Exp 01/28/24)

0001411232 (Exp 03/28/24)

0001423157 (Exp 06/28/24)

0001427153 (Exp 07/28/24)

0001439097 (Exp 10/28/24)

0001450208 (Exp 12/28/24)

0001465424 (Exp 04/28/25)

0001481263 (Exp 07/28/25)

0001501269 (Exp 12/28/25)

Product: Bard Mission Disposable Core Biopsy Instrument Kit 20G x 10CM

Model / REF:

2010MSK

UPC Codes:

00801741097089

Lot Numbers:

0001390416 (Exp 10/28/23)

0001402093 (Exp 01/28/24)

0001414353 (Exp 03/28/24)

0001418626 (Exp 05/28/24)

0001432741 (Exp 08/28/24)

0001445947 (Exp 11/28/24)

0001448749 (Exp 12/28/24)

0001456597 (Exp 02/28/25)

0001461729 (Exp 03/28/25)

0001479643 (Exp 06/28/25)

0001488082 (Exp 08/28/25)

0001490705 (Exp 09/28/25)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93578

Status: Active

Manufacturer: Bard Peripheral Vascular Inc

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 1,243,937