Z-1088-2017Class II

Atrium Medical 16400 Express Mini 500 dry seal drain

Name: Z-1088-2017 Atrium Medical 16400 Express Mini 500 dry seal drain
Creator: Atrium Medical Corporation
Published: 2016-11-29
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2016-11-29 / Terminated / root cause: packaging

FDA source

Atrium Medical Corporation began a recall of Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish... on 2016-11-29. FDA classified it as Class II and gives the reason as "Outer Packaging is not sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1088-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Posted: 2017-01-24
Terminated: 2020-09-29
Recalling firm: Atrium Medical Corporation
Product: Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: 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 patient s pleural cavity or mediastinal area.
Product code: PAD Chest Drainage Kit
Reason for recall: Outer Packaging is not sterile
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Atrium Medical issued recall letter on 11/29/16 via two-day express mail delivery advising users: of the problem, updated instructions for use; the new Warning Label applied to the packaging; and requesting to post the warning label near all Atrium chest drain product inventory. A Field Notification Reply Form acknowledging receipt of the Field Notification was requested to be completed and returned. Questions contact 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).
Quantity in commerce: 964,463 cases (US) 521,975 cases (OUS) in total
Distribution: Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
Product codes and lots: All Lot Numbers With Expiration Date Prior To October 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1088-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1079-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1080-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1081-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1082-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1083-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1084-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1085-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1086-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1087-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24
Z-1088-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24

Product code PAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)