Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

FDA device recall Z-0027-2024 · posted 2023-10-04 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

KNW

Quantity affected

1,545

Distribution

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.

Date initiated

2023-08-10

Date posted

2023-10-04

Location

Tempe, AZ

Related 510(k) clearances