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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Express Dry Seal Chest Drain ATS Blood Recovery

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 Class 2 Recall
Atrium Express Dry Seal Chest Drain ATS Blood Recovery
see related information
Date Posted July 01, 2014
Recall Status1 Open
Recall Number Z-1959-2014
Recall Event ID 68398
Premarket Notification
510(K) Numbers
K043140  K043582 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Code Information Lot Number: 10906458
Recalling Firm/
Manufacturer
Atrium Medical Corporation
5 Wentworth Dr
Hudson, New Hampshire 03051-4929
Manufacturer Reason
for Recall
Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Smith & Nephew notified Distributors on April 28, 2014 by telephone. A follow up e-mail and a recall notification letter were issued by UPS on 6/27/14. Distributors were requested to notify customers who received the lot. A reply acknowledgement form was to be completed and returned. Return Goods Authorizations for the return of the goods were issued to customers.
Quantity in Commerce 195 Cases; Total 1170 units
Distribution Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
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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