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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81076

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

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Event summary

Timeline bucket
August 10, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
A M Systems 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

Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.

Z-0120-2019
Recall number
Z-0120-2019
Initiated
August 10, 2018
Classification
Class II
Status
Terminated
Recalling firm
A M Systems Inc
Quantity
610

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

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

Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Code information

Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567

Distribution pattern

US Distribution to states of: OH, PA, and NC.

Field note

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