Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85730

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

Open FDA event record

Event summary

Timeline bucket
May 26, 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

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Z-2485-2020
Recall number
Z-2485-2020
Initiated
May 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD Inc.
Quantity
20 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.

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

One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.

Code information

Model Number: 60HA30, Lot: 3794165, SKU 60HA30

Distribution pattern

U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.