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U.S. Department of Health and Human Services

Class 2 Device Recall Marquee Disposable Core Biopsy Instrument and Kit

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 Class 2 Device Recall Marquee Disposable Core Biopsy Instrument and Kitsee related information
Date Initiated by FirmSeptember 30, 2024
Date PostedNovember 15, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0467-2025
Recall Event ID 95491
510(K)NumberK133948 
Product Classification Instrument, biopsy - Product Code KNW
ProductBard 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
Code Information 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)
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438
For Additional Information Contact
480-303-2602
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionOn 9/30/24, removal notices were sent to customers who were asked to do the following: 1) Discontinue use of product listed in the letter, and immediately dispose of all affected product remaining in your possession in accordance with your local facility s process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, please share this notice to ensure that these entities are contacted and informed of the recall. 3) Complete and return the response form via email to BDRC27@BD.COM - If you purchased this product from a distributor, contact your distributor for further instructions and resolution. - Affected lots distributed from 05 April 2023 through 23 Aug 2024. If further assistance is required contact the firm: - North American Regional Complaint Center: 1-844-823-5433, Mon - Fri 8:00am and 5:00pm CT, productcomplaints@bd.com - Recall Related Questions: BDRC27@BD.COM On 1/15/2025, additional removal notices were mailed or emailed to distributors informing them of additional affected devices.
Quantity in Commerce71,498
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KNW
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