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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94453

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

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Event summary

Timeline bucket
April 17, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Integra LifeSciences Corp.

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

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

Z-1873-2024
Recall number
Z-1873-2024
Initiated
April 17, 2024
Classification
Class II
Status
Ongoing
Quantity
1,822 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging (header bag) of the Cranial Access Kit may compromise

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

Code information

UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025

Distribution pattern

Worldwide distribution - US Nationwide and the countries of CA, BE, CL.