—#203206

Product

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K133948
Affected lot / code info: UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025

Why it was recalled

Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.

Root cause (FDA determination)

Device Design

Action the firm took

On 8/10/23, BD mailed or emailed recall notices to Medical Directors, Risk Managers, Medical Device Safety Offices, Lab Managers, Clinical Engineers, and Distributors who were told to do the following: 1) Discontinue distribution and use and immediately dispose of all affected product. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. 3) Distributors, identify all customers within your distribution network that purchased any affected product and provide a copy of the customer letter to all customers and advise them of this field action notification on behalf of the recalling firm. 2) Complete the attached Response Form and return via email to: BDRC45@bd.com If you require further assistance contact: the North American Regional Complaint Center: 1-844-8BD- LIFE (1-844-823-5433) M-F 8am - 5pm CT, or Email: productcomplaints@bd.com

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA, OR, AZ, NJ, NY, OH, NC, MD, MI, LA, IN, AK, TN and the countries of CA, AU, BE.

Timeline

Recall initiated: 2023-08-10
Posted by FDA: 2023-10-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203206. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.