Z-0500-2007

Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

Name: Z-0500-2007 Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
Creator: Atrium Medical Corporation
Published: 2006-11-08
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2006-11-08 / Terminated

FDA source

Atrium Medical Corporation began a recall of Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N on 2006-11-08. The reason FDA records is "Chest drainage tubing incorrectly assembled and may disconnect from patient during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0500-2007
Status: Terminated
Initiated: 2006-11-08
Posted: 2007-02-15
Terminated: 2007-11-27
Recalling firm: Atrium Medical Corporation
Product: Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Chest drainage tubing incorrectly assembled and may disconnect from patient during use
FDA root cause: Other
Action: Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.
Quantity in commerce: 49 cases ( 294 units)
Distribution: Nationwide, including CA, and PA.
Product codes and lots: Lot Numbers; 10137320, 10116878, 10101974

Product code CAC

K043140Class IIExpress and Oasis Chest DrainAtrium Medical Corp. / cleared 2004-12-08

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)