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.
FDA Recall Z-0736-2014 · Posted 2014-01-14
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Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2013-11-19
Date Terminated2015-06-11
Product Quantity624 units
Reason for Recall
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Firm Action
Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line.
International Distributors. International distributors provided with the Recall Authorization' package and the customer letter.
Accounts are requested to complete the Recall Reply Form acknowledging receipt of the notification.
Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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