Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Summary
The FDA issued a Class II for Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 by Bard Peripheral Vascular Inc. Reason: Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diame.
Details
Source
Device Recall
External ID
Z-0027-2024
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Lot/Code Info: UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025
Quantity Affected: 1,545
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-10
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Peripheral Vascular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bard Peripheral Vascular Inc have FDA actions?
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0027-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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