FDAClass IIOctober 11, 2023

Bard Marquee Disposable Core Biopsy Instrument Kit recall

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

Why was Bard Marquee Disposable Core Biopsy Instrument Kit 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025

Product
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Recalling firm
Bard Peripheral Vascular Inc
Quantity
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.
Recall date
October 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls