Device recall
Z-2469-2008: Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-2469-2008 |
|---|---|
| Recall event | 49378 |
| 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… |
| Product code | DTZ |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2008 |
| 510(k) numbers | K991737 |
| FEI number | 1718850 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database