Atrium Medical Corporation: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Agency Publication Date: January 14, 2014

Affected Products

Product: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Product: Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers). To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot Numbers:

number

Product: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Product: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Product: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346. ( All units in between and including these two numbers)

Lot Numbers:

number

Product: Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Product: Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346. All units in between and including these two numbers.

Lot Numbers:

number

Product: Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)

Lot Numbers:

number

Product: Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66788

Status: Resolved

Manufacturer: Atrium Medical Corporation

Manufactured In: United States

Units Affected: 9 products (10,448 units; 624 units; 6,684 units; 361 units; 1,002 units; 42,699 units; 954 units; 7,274 units; 1,944 units)

Were You Affected by This Recall?

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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

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers). To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot Numbers:

number

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Lot number starting with 10883097 and the ending lot number 10913346. ( All units in between and including these two numbers)

Lot Numbers:

number

Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)

Lot Numbers:

number

Lot number starting with 10883097 and the ending lot number 10913346. All units in between and including these two numbers.

Lot Numbers:

number

Product: Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.

Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)

Lot Numbers:

number

Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)

Lot Numbers:

number