Z-0027-2024 Class II Ongoing
FDA device recall Z-0027-2024 was initiated by Bard Peripheral Vascular Inc on August 10, 2023 and is designated Class II. 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)… The recall status is ongoing. Affected quantity: 1,545.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- August 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,545
Product Description
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
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 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.
Code Information
UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025