Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86,
FDA device recall Z-2469-2008 · posted 2008-09-30 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Under certain conditions, venous reservoir on oxygenator may allow air into the system.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 35 units
- Distribution
- NC
- Date initiated
- 2008-08-08
- Date posted
- 2008-09-30
- Date terminated
- 2008-09-30
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR (K991737) | Dideco S.P.A. | 2000-02-17 |