Exact FDA event identifier

Event 65449

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

Open FDA event record

Event summary

Timeline bucket: April 17, 2013
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Bryan Medical 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

Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

Z-1667-2013

Recall number: Z-1667-2013
Initiated: April 17, 2013
Classification: Class I
Status: Terminated
Recalling firm: Bryan Medical Inc
Quantity: 5 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Code information

The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752

Distribution pattern

Distributed in KY and AL.