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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium

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 Class 2 Recall
Atrium
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on November 27, 2007
Recall Number Z-0500-2007
Recall Event ID 36925
Premarket Notification
510(K) Number
K043140 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
Code Information Lot Numbers; 10137320, 10116878, 10101974
Recalling Firm/
Manufacturer
Atrium Medical Corporation
5 Wentworth Dr
Hudson, New Hampshire 03051-4929
For Additional Information Contact Karen Hall
603-880-1433
Manufacturer Reason
for Recall
Chest drainage tubing incorrectly assembled and may disconnect from patient during use
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.
Quantity in Commerce 49 cases ( 294 units)
Distribution Nationwide, including CA, and PA.
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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