Recall Z-0467-2025 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
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
| Date | Nov 15, 2024 (initiated Sep 30, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| Action | On 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 vi |
| Quantity | 71,498 |
| 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, Unit |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT Bard Peripheral Vascular, Inc., Feb 21, 2014 |