Reported Dec 1, 2021 · Ongoing
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection…
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- 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 incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.
- Lot codes and dates
- Product Code/REF Number 2002-400
- Lot codes
441533443300443608443629444473445527448966449683450899450900451270451988452177452814454577455871458264458604459198459642462192462194464075464076465037466247469921470627471651471703472562472785 and 473725
- UDI Code00650862100211
- Amount recalled
- 87,972 drains (14,662 cases; 6 units/case)
Where it was sold
- Nationwide
Why it was recalled
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
This product could cause temporary or reversible health problems — stop using it.
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