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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 Recoverysee related information
Date Initiated by FirmApril 28, 2014
Date PostedJuly 01, 2014
Recall Status1 Terminated 3 on March 17, 2016
Recall NumberZ-1959-2014
Recall Event ID 68398
510(K)NumberK043140 K043582 
Product Classification Apparatus, autotransfusion - Product Code CAC
ProductAtrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Code Information Lot Number: 10906458
FEI Number 3011175548
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
ActionSmith & 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 Commerce195 Cases; Total 1170 units
DistributionDistributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAC
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