Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 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
FDA Recall Z-1206-2017 · Posted None
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Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeKDQ
Date Initiated2016-12-23
Date Terminated2020-11-03
Product Quantity27 cases (162 units)
Reason for Recall
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Firm Action
Maquet 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: [email protected] 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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