Date Initiated by Firm |
November 08, 2006 |
Date Posted |
February 15, 2007 |
Recall Status1 |
Terminated 3 on November 27, 2007 |
Recall Number |
Z-0500-2007 |
Recall Event ID |
36925 |
510(K)Number |
K043140
|
Product Classification |
chest drain - 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 NH 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 |
Other |
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
|
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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.
|
510(K) Database |
510(K)s with Product Code = CAC and Original Applicant = ATRIUM MEDICAL CORP.
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