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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Medical

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 Class 2 Device Recall Atrium Medicalsee related information
Date Initiated by FirmDecember 23, 2016
Create DateFebruary 15, 2017
Recall Status1 Terminated 3 on November 03, 2020
Recall NumberZ-1205-2017
Recall Event ID 75707
510(K)NumberK043582 
Product Classification Bottle, collection, vacuum - Product Code KDQ
ProductMaquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.
Code Information Lot Number: 242896, 243292
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
For Additional Information Contact
603-880-1433
Manufacturer Reason
for Recall		Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
FDA Determined
Cause 2		Process control
ActionMaquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode. Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: drainsmvv.us@getinge.com or you may fax the form to 1-603-386-6590. Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST). UPDATE: On 1/16/17, Maquet issued recall letters that identified correct lot numbers and products in the letter titles: UPDATE-UPDATED AFFECTED DEVICES. Two letters issued one to customers who received the Dec 23 letter and one to new customers who who did not receive the Dec. 23 letter.
Quantity in Commerce245 cases (1470 units)
DistributionWorldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
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 = KDQ
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