Z-0664-2018Class III

Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the...

Name: Z-0664-2018 Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the...
Creator: LivaNova USA
Published: 2017-12-19
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2017-12-19 / Terminated / root cause: manufacturing process

FDA source

LivaNova USA began a recall of Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO on 2017-12-19. FDA classified it as Class III and gives the reason as "The product is labeled with the incorrect expiration date". 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-0664-2018
Classification: Class III
Status: Terminated
Initiated: 2017-12-19
Posted: 2018-02-21
Terminated: 2020-08-11
Recalling firm: LivaNova USA, Inc.
Product: Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: The product is labeled with the incorrect expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.
Quantity in commerce: 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
Distribution: Distribution was made to one consignee in LA.
Product codes and lots: Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0664-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0664-2018	Class III	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code DWE

K981613Class IICobe Smarxt Tubing and ConnectorsCobe Cardiovascular, Inc. / cleared 1998-10-26

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)