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.
|