The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chambe
Summary
The FDA issued a Class II for The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection de by Atrium Medical Corporation. Reason: Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient.
Details
Source
Device Recall
External ID
Z-0307-2022
Action Date
2021-12-01
Status
Ongoing
Category
device
Product Description
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/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
Quantity Affected: 87,972 drains (14,662 cases; 6 units/case)
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-22
Company
Merrimack, NH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Atrium Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Atrium Medical Corporation have FDA actions?
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0307-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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