Z-2469-2008

Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale...

Name: Z-2469-2008 Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale...
Creator: Sorin Group USA, Inc.
Published: 2008-08-08
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2008-08-08 / Terminated / root cause: labeling and UDI

FDA source

Sorin Group USA, Inc. began a recall of Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The... on 2008-08-08. The reason FDA records is "Under certain conditions, venous reservoir on oxygenator may allow air into the system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2469-2008
Status: Terminated
Initiated: 2008-08-08
Posted: 2008-09-30
Terminated: 2008-09-30
Recalling firm: LivaNova USA, Inc.
Product: Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmonary bypass circuits as a device to replace the function of the lungs in order to control the arterial/venous temperature and as a venous blood reservoir
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Under certain conditions, venous reservoir on oxygenator may allow air into the system.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The firm sent out a notification letter, by certified letter, on Aug 8,2008. Instructions on how to prevent air from entering the system were provided. Sorin Group USA, Inc. can reached at 1-303-467-6306.
Quantity in commerce: 35 units
Distribution: NC
Product codes and lots: Lot No: 0501210038, and 0710290112.

Product code DTZ

K991737Class IILilliput Phospholypidic Inert Surface in Oxygenation (Ph.i.s.i.o.) Infant/newborn Hollow Fiber OxygenatorDideco S.P.A. / cleared 2000-02-17

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)