Sorin Group USA, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Sorin Group USA, Inc.
Lot Codes / Batch Numbers
Lot No: 0501210038, and 0710290112.
Products Sold
Lot No: 0501210038, and 0710290112.
Sorin Group USA, Inc. is recalling Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via due to Under certain conditions, venous reservoir on oxygenator may allow air into the system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under certain conditions, venous reservoir on oxygenator may allow air into the system.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC
Page updated: Jan 10, 2026