Exact FDA event identifier

Event 95241

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

Open FDA event record

Event summary

Timeline bucket: August 08, 2024
Product types: Device
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: T.G. Eakin Limited

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

eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

Z-3263-2024

Recall number: Z-3263-2024
Initiated: August 08, 2024
Classification: Class III
Status: Ongoing
Recalling firm: T.G. Eakin Limited
Quantity: 35,400 cartons of 20 individually packaged seals

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.

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

On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.

Code information

UDI/DI 00768455108732, Lot number 109357C553

Distribution pattern

US: KY