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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71023

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 07, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Atrium Medical Corporation

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

4 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 4

Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000

Z-1935-2015
Recall number
Z-1935-2015
Initiated
May 07, 2015
Classification
Class II
Status
Terminated
Quantity
390 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Chest drains have a missing o-ring

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

Chest drains have a missing o-ring

Code information

Lot Number: 222511

Distribution pattern

Nationwide Canada, Germany

device · product 2 of 4

Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100

Z-1936-2015
Recall number
Z-1936-2015
Initiated
May 07, 2015
Classification
Class II
Status
Terminated
Quantity
130 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Chest drains have a missing o-ring

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

Chest drains have a missing o-ring

Code information

Lot Number: 222945

Distribution pattern

Nationwide Canada, Germany

device · product 3 of 4

Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100

Z-1937-2015
Recall number
Z-1937-2015
Initiated
May 07, 2015
Classification
Class II
Status
Terminated
Quantity
1170 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Chest drains have a missing o-ring

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

Chest drains have a missing o-ring

Code information

Lot Numbers: 222115, 222118, 222528

Distribution pattern

Nationwide Canada, Germany

device · product 4 of 4

EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N

Z-1938-2015
Recall number
Z-1938-2015
Initiated
May 07, 2015
Classification
Class II
Status
Terminated
Quantity
390 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Chest drains have a missing o-ring

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

Chest drains have a missing o-ring

Code information

Lot Number: 222516

Distribution pattern

Nationwide Canada, Germany