Z-1959-2014Class II

Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus

Name: Z-1959-2014 Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus
Creator: Atrium Medical Corporation
Published: 2014-04-28
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2014-04-28 / Terminated / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus on 2014-04-28. FDA classified it as Class II and gives the reason as "Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error". 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-1959-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-28
Posted: 2014-07-01
Terminated: 2016-03-17
Recalling firm: Atrium Medical Corporation
Product: Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Smith & Nephew notified Distributors on April 28, 2014 by telephone. A follow up e-mail and a recall notification letter were issued by UPS on 6/27/14. Distributors were requested to notify customers who received the lot. A reply acknowledgement form was to be completed and returned. Return Goods Authorizations for the return of the goods were issued to customers.
Quantity in commerce: 195 Cases; Total 1170 units
Distribution: Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
Product codes and lots: Lot Number: 10906458

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1959-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1959-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

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)