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