Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10
Summary
The FDA issued a Class II for Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 C by Bard Peripheral Vascular Inc. Reason: Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate secur.
Details
Source
Device Recall
External ID
Z-0467-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
Lot/Code Info: REF/UDI-DI/Lot(Expiration): MQK1210/00801741097263/1490758(9/28/2025), 1506044(1/28/2026), 1506045(1/28/2026), 1511827(2/28/2026), 1514692(3/28/2026), 1518977(4/28/2026), 1518978(4/28/2026), 1518979(4/28/2026), 1519143(4/28/2026), 1520507(5/28/2026), 1520508(5/28/2026), 1522157(5/28/2026), 1522158(5/28/2026), 1522577(5/28/2026), 1523785(6/28/2026), 1523914(6/28/2026), 1523915(6/28/2026), 1525370(6/28/2026), 1525371(6/28/2026), 1525373(6/28/2026), 1528417(7/28/2026), 1528418(7/28/2026), 1528495(7/28/2026), 1528496(7/28/2026), 1528497(7/28/2026), 1528560(7/28/2026), 0001618867(3/28/2028), 0001620281(3/28/2028), 0001632675(6/28/2028); MQ1210/00801741097119/1514460(3/28/2026), 1514461(3/28/2026), 1519144(4/28/2026), 1519145(4/28/2026), 1519456(4/28/2026), 1520066(5/28/2026), 1520067(5/28/2026), 1520506(5/28/2026), 1523783(6/28/2026), 1523784(6/28/2026), 0001618258(3/28/2028), 0001631611(6/28/2028), 0001633216(7/28/2028); MQK1213/00801741097270/1543517(10/28/2026), 1559312(2/28/2027), 1562724(3/28/2027), 1569737(4/28/2027), 1581652(7/28/2027); MQ1213/00801741097126/1558191(2/28/2027), 1559313(2/28/2027)
Quantity Affected: 71,498
Reason for Recall
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.
Distribution
Worldwide - US Nationwide including in the states of WA, LA, MN, PA, UT, SC, OK, KY, AZ, IL, TX, NJ, NY, FL, TN, IN, OH, NC, CO, VA, GA, MD, CA, AL, WI, MO, IA, CT, NE, MI, MS, NV, KS, OR, SD, ID, NH, RI, WY, AR, MA, DE, ND, NM, AK, PR and the countries of Portugal, Spain, South Africa, Greece, United Arab Emirates, United Kingdom, Sweden, Finland, Belgium, Korea, Australia, Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-30
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Peripheral Vascular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bard Peripheral Vascular Inc have FDA actions?
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0467-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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