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 |
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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.
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510(K) Database | 510(K)s with Product Code = CAC
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