Device recall
Z-2795-2011: XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF…
FDA device recall · Class II · Vitrolife, Inc.
Key facts
| Recall number (Z-number) | Z-2795-2011 |
|---|---|
| Recall event | 58824 |
| Product | XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018. |
| Product code | MSB |
| Recalling firm | Vitrolife, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 15, 2011 |
| 510(k) numbers | K081997 |
| FEI number | 3003274090 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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