Device recall
Z-1111-2017: SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery…
FDA device recall · Class II · Organ Recovery Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1111-2017 |
|---|---|
| Recall event | 75978 |
| Product | SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 |
| Product code | KDL |
| Recalling firm | Organ Recovery Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 14, 2019 |
| 510(k) numbers | K091656 |
| FEI number | 3004068499 |
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