Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75347

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

Open FDA event record

Event summary

Timeline bucket
October 26, 2016
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

8 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 8

Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0576-2017
Recall number
Z-0576-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
1617 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

device · product 2 of 8

Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0577-2017
Recall number
Z-0577-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
2822 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

device · product 3 of 8

Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0578-2017
Recall number
Z-0578-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
2697 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

device · product 4 of 8

Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0579-2017
Recall number
Z-0579-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
2172 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

device · product 5 of 8

Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0580-2017
Recall number
Z-0580-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
4836 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

device · product 6 of 8

Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0581-2017
Recall number
Z-0581-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
5005 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

device · product 7 of 8

Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0582-2017
Recall number
Z-0582-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
7043 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

device · product 8 of 8

Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Z-0583-2017
Recall number
Z-0583-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
5055 cases (10/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Code information

All lot codes

Distribution pattern

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.