Atrium Medical Corporation: The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal ch

Is my product affected?

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporate

• UPC 00650862100211

Check against the official notice below — it lists the full affected range.

What happened

Atrium Medical Corporation is recalling 87,972 Ocean Water Seal Chest Drain units distributed nationwide in the US and internationally to countries including Canada, Mexico, the United Kingdom, and others. The three-bottle vacuum collection device is used to collect mediastinal blood after chest surgery. The recall was initiated because the product's set-up instructions are inadequate or inappropriate, which may delay treatment and create an unreasonable risk of harm to patients.

The affected drains have Product Code/REF Number 2002-400 and lot codes ranging from 441533 to 473725. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

Details from the source

Reason for recall: Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient Distribution: US Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada Colombia Ecuador Finland Italy Kuwait Libya Mauritius Mexico Netherlands Poland Portugal Russian Federation Saudi Arabia Spain United Arab Emirates United Kingdom of Great Britain and Northern Ireland Quantity: 87,972 drains (14,662 cases; 6 units/case) Lot/code info: Product Code/REF Number 2002-400; Lot codes: 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651,471703, 472562, 472785 and 473725. UDI Code: 00650862100211

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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