Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1564-2023 — Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM

U.S. FDA — Device Enforcement · United States · 2023-04-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1564-2023
Date of alert
2023-04-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bard Peripheral Vascular Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00801741097089
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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