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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 Device Recall Atrium Express Dry Seal Chest Drain ATS Blood Recovery see related information
Date Initiated by Firm April 28, 2014
Date Posted July 01, 2014
Recall Status1 Terminated 3 on March 17, 2016
Recall Number Z-1959-2014
Recall Event ID 68398
510(K)Number 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 NH 03051-4929
For Additional Information Contact
603-880-1433
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = ATRIUM MEDICAL CORP.
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