Exact FDA event identifier

Event 84296

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

Open FDA event record

Event summary

Timeline bucket: November 15, 2019
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Tytek 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

PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

Z-0930-2020

Recall number: Z-0930-2020
Initiated: November 15, 2019
Classification: Class I
Status: Terminated
Recalling firm: Tytek Medical Inc
Quantity: 3,565 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A defect involving an occluded needle was discovered during a training exercise.

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

A defect involving an occluded needle was discovered during a training exercise.

Code information

NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026

Distribution pattern

US (nationwide), and countries of: Europe, Australia and Hong Kong.