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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64075

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

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Event summary

Timeline bucket
August 22, 2012
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Viscot Medical LLC

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

Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

Z-1025-2013
Recall number
Z-1025-2013
Initiated
August 22, 2012
Classification
Class III
Status
Terminated
Recalling firm
Viscot Medical LLC
Quantity
458,589 markers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dual Tip Marker has inconsistent ink flow on the black permanent ink side.

Code information

Lot# 022043, 022045, 022046, 042084, 042085, 042086, 042087, 042088, 042089, 052128, 052129, 052130, 052131, 062167, 062168, 062169, 062170, 072200, 072201, 072203, 072205, 072206, 072207 (Including any letter suffixes after lot #).

Distribution pattern

USA Nationwide Distribution

Field note

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