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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70662

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

Open FDA event record

Event summary

Timeline bucket
February 19, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Arc 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

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

Z-1596-2015
Recall number
Z-1596-2015
Initiated
February 19, 2015
Classification
Class III
Status
Terminated
Recalling firm
Arc Medical Inc
Quantity
1810 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

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

Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

Code information

Product code: 6160, Batch number: 110208-50

Distribution pattern

Distributed in CA and NC.