Z-0736-2014Class II

Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile...

Name: Z-0736-2014 Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile...
Creator: Atrium Medical Corporation
Published: 2013-11-19
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2013-11-19 / Terminated / root cause: design

FDA source

Atrium Medical Corporation began a recall of Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To... on 2013-11-19. FDA classified it as Class II and gives the reason as "Chest Drain tubing of of the ATS Blood recovery may leak or disconnect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0736-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-19
Posted: 2014-01-14
Terminated: 2015-06-11
Recalling firm: Atrium Medical Corporation
Product: Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Root cause tag: design
FDA root cause: Device Design
Action: Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line. International Distributors. International distributors provided with the Recall Authorization' package and the customer letter. Accounts are requested to complete the Recall Reply Form acknowledging receipt of the notification. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.
Quantity in commerce: 624 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
Product codes and lots: Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers). To evacuate air and/or fluid from the chest cavity or mediastinum.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0736-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0735-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0736-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0737-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0738-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0739-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0740-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0741-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0742-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0743-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14

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)