Exact FDA event identifier

Event 82387

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

Open FDA event record

Event summary

Timeline bucket: February 11, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Smiths Medical ASD 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

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

Z-1732-2019

Recall number: Z-1732-2019
Initiated: February 11, 2019
Classification: Class II
Status: Terminated
Recalling firm: Smiths Medical ASD Inc.
Quantity: 7,840

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Packaged with an incorrect size inner cannula.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaged with an incorrect size inner cannula.

Code information

Item code/product number: 100/856/080 lot number: 3578884

Distribution pattern

Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland