Z-1096-2010

Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004...

Name: Z-1096-2010 Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004...
Creator: Sorin Group USA, Inc.
Published: 2009-12-30
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2009-12-30 / Terminated / root cause: packaging

FDA source

Sorin Group USA, Inc. began a recall of Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring... on 2009-12-30. The reason FDA records is "Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility". 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-1096-2010
Status: Terminated
Initiated: 2009-12-30
Posted: 2010-03-12
Terminated: 2010-03-15
Recalling firm: LivaNova USA, Inc.
Product: Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.
Quantity in commerce: 17 units
Distribution: AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
Product codes and lots: Lot Number: 0932800048.

Product code DWF

K881330Class IICobe Heart/lung Perfusion and Cardioplegia PackCobe Laboratories, Inc. / cleared 1988-06-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)