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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86828

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

Open FDA event record

Event summary

Timeline bucket
November 10, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Applied Medical Technology 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

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

Z-0698-2021
Recall number
Z-0698-2021
Initiated
November 10, 2020
Classification
Class III
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

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 products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

Code information

Box Lot Number 200918-103; Pouch Lot Number 200902-075

Distribution pattern

US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.