Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM
FDA device recall Z-0467-2025 · posted 2024-11-15 · Open, Classified
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- 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.
- Action taken
- 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 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- KNW
- Quantity affected
- 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,
- Date initiated
- 2024-09-30
- Date posted
- 2024-11-15
- Location
- Tempe, AZ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT (K133948) | Bard Peripheral Vascular, Inc. | 2014-02-21 |