Recall Z-2469-2008 ยท DTZ Oxygenator, Cardiopulmonary Bypass
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
| Date | Sep 30, 2008 (initiated Aug 8, 2008) |
| Status | Terminated |
| Reason | Under certain conditions, venous reservoir on oxygenator may allow air into the system. |
| 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 | 35 units |
| Distribution | NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991737 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR Dideco S.P.A., Feb 17, 2000 |