Atrium Medical Corporation: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

Agency Publication Date: February 15, 2017

Affected Products

Product: Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.

Lot Number: 242896, 243292

Lot Numbers:

Number

Product: Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Lot Number: 242897

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Number

Product: Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Lot Number: 242909, 242910, 242912, 242914, 242915

Lot Numbers:

Number

Product: Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Lot Number: 242919, 242920

Lot Numbers:

Number

Product: Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Lot Number: 243295

Lot Numbers:

Number

Product: Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Lot Number: 243842

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Number

Product: Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Lot Number: 243312

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75707

Status: Resolved

Manufacturer: Atrium Medical Corporation

Manufactured In: United States

Units Affected: 7 products (245 cases (1470 units); 27 cases (162 units); 2933 cases (17598 units); 681 cases (4086 units); 1 case (6 units); 1 case (6 units); 3 cases (18 units))

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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

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Affected Products

Lot Number: 242896, 243292

Lot Numbers:

Number

Lot Number: 242897

Lot Numbers:

Number

Lot Number: 242909, 242910, 242912, 242914, 242915

Lot Numbers:

Number

Lot Number: 242919, 242920

Lot Numbers:

Number

Lot Number: 243295

Lot Numbers:

Number

Lot Number: 243842

Lot Numbers:

Number

Lot Number: 243312

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75707

Status: Resolved

Manufacturer: Atrium Medical Corporation

Manufactured In: United States

Units Affected: 7 products (245 cases (1470 units); 27 cases (162 units); 2933 cases (17598 units); 681 cases (4086 units); 1 case (6 units); 1 case (6 units); 3 cases (18 units))