Exact FDA event identifier

Event 86345

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

Open FDA event record

Event summary

Timeline bucket: August 28, 2020
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

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.

Z-2946-2020

Recall number: Z-2946-2020
Initiated: August 28, 2020
Classification: Class II
Status: Terminated
Recalling firm: Smiths Medical ASD Inc.
Quantity: 3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Label has the incorrect

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

Label has the incorrect size for the tracheotomy tube.

Code information

Lot# 3952216

Distribution pattern

US Distribution to state of: CT