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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64135

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

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Event summary

Timeline bucket
January 17, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Carestream Health, 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

KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography

Z-0744-2013
Recall number
Z-0744-2013
Initiated
January 17, 2013
Classification
Class III
Status
Terminated
Recalling firm
Carestream Health, Inc.
Quantity
101 cartons: Domestic - 95 cartons; Foreign - 6 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label. The expiration dating symbol is missing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a

Code information

Lot 2114596 (Exp. September 2014)

Distribution pattern

US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.

Field note

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