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

Agency Publication Date: November 16, 2016

Affected Products

Product: 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.

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Product: 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.

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Product: 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.

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Product: 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.

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Product: 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.

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Product: 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.

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Product: 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.

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Product: 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.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75347

Status: Resolved

Manufacturer: Atrium Medical Corporation

Manufactured In: United States

Units Affected: 8 products (1617 cases (10/cs); 2822 cases (10/cs); 2697 cases (10/cs); 2172 cases (10/cs); 4836 cases (10/cs); 5005 cases (10/cs); 7043 cases (10/cs); 5055 cases (10/cs))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 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.

All lot codes

Lot Numbers:

codes

Product: 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.

All lot codes

Lot Numbers:

codes

Product: 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.

All lot codes

Lot Numbers:

codes

Product: 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.

All lot codes

Lot Numbers:

codes

Product: 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.

All lot codes

Lot Numbers:

codes

Product: 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.

All lot codes

Lot Numbers:

codes

Product: 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.

All lot codes

Lot Numbers:

codes

Product: 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.

All lot codes

Lot Numbers:

codes

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75347

Status: Resolved

Manufacturer: Atrium Medical Corporation

Manufactured In: United States

Units Affected: 8 products (1617 cases (10/cs); 2822 cases (10/cs); 2697 cases (10/cs); 2172 cases (10/cs); 4836 cases (10/cs); 5005 cases (10/cs); 7043 cases (10/cs); 5055 cases (10/cs))