Device recall
Z-1387-2018: Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog…
FDA device recall · Class II · Preservation Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-1387-2018 |
|---|---|
| Recall event | 79378 |
| Product | Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a… |
| Product code | KDN |
| Recalling firm | Preservation Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2022 |
| 510(k) numbers | K073693 |
| FEI number | 1000221028 |
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