FDA Device recall Z-1564-2023
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM
- FDA Device
- Class II
- ongoing
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class II recall of Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM by Bard Peripheral Vascular, citing coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fittin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1564-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-11 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Reason
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
Identifiers
| code_info | REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025) |
|---|
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-1564-2023%22
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