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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Medical Ocean Water Seal Chest Drain ATS

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 Class 2 Recall
Atrium Medical Ocean Water Seal Chest Drain ATS
see related information
Date Posted January 14, 2014
Recall Status1 Open
Recall Number Z-0735-2014
Recall Event ID 66788
Premarket Notification
510(K) Numbers
K043140  K043582 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
Code Information Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
Recalling Firm/
Manufacturer
Atrium Medical Corporation
5 Wentworth Dr
Hudson, New Hampshire 03051-4929
For Additional Information Contact Kenneth Collins
603-880-1433
Manufacturer Reason
for Recall
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 10,448 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = ATRIUM MEDICAL CORP.
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