FDA Device recall Z-0027-2024
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 by Bard Peripheral Vascular, citing diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy need….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0027-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-10 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Reason
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.
Identifiers
| code_info | UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Bard Peripheral Vascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0027-2024%22
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