Z-1208-2017Class II

Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N

Name: Z-1208-2017 Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N
Creator: Atrium Medical Corporation
Published: 2016-12-23
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2016-12-23 / Terminated / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or... on 2016-12-23. FDA classified it as Class II and gives the reason as "Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1208-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Posted: 2017-02-15
Terminated: 2020-11-03
Recalling firm: Atrium Medical Corporation
Product: Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N 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
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 681 cases (4086 units)
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
Product codes and lots: Lot Number: 242919, 242920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1208-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1205-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15
Z-1206-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15
Z-1207-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15
Z-1208-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15
Z-1209-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15
Z-1210-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15
Z-1211-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15

Product code CAC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)