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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92994

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 10, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Bard Peripheral Vascular Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

Z-0027-2024
Recall number
Z-0027-2024
Initiated
August 10, 2023
Classification
Class II
Status
Ongoing
Quantity
1,545

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025

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.