FDA Recall
Terminated
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: Z-2469-2008
·
Initiated August 8, 2008
Recall
- Recall Number
- Z-2469-2008
- Event Number
- 49378
- Firm
- Sorin Group USA, Inc.
- FEI Number
- 1718850
- Product Code
- DTZ
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- August 8, 2008
- Posted
- September 30, 2008
- Terminated
- September 30, 2008
- Address
- 14401 W 65th Way, Arvada, CO, 80004
Description
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
Reason
Under certain conditions, venous reservoir on oxygenator may allow air into the system.
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.
Distribution
NC
Quantity
35 units