Z-0377-2011

Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin Group USA, Inc. 14401...

Name: Z-0377-2011 Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin Group USA, Inc. 14401...
Creator: Sorin Group USA, Inc.
Published: 2010-10-07
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2010-10-07 / Terminated / root cause: packaging

FDA source

Sorin Group USA, Inc. began a recall of Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in... on 2010-10-07. The reason FDA records is "Defective product packaging may compromise product 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-0377-2011
Status: Terminated
Initiated: 2010-10-07
Posted: 2010-11-15
Terminated: 2010-12-17
Recalling firm: LivaNova USA, Inc.
Product: Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by 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: Defective product packaging may compromise product sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.
Quantity in commerce: 69
Distribution: Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
Product codes and lots: Lot No. 1013100022, 1016700043, 1018200024, 1022300025

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)