Class II — Preservation Solutions, Inc.
| Recalling firm | PRESERVATION SOLUTIONS, INC. |
|---|---|
| Registered facility | PRESERVATION SOLUTIONS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.. |
| 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 recipient. |
| Quantity | 31,104 units |
| Distribution | Worldwide Distribution -- USA and Europe. |
| Initiated | 2018-02-26 |
| Classified | 2018-04-16 |
| Terminated | 2022-09-09 |
| Recall number | Z-1387-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Preservation Solutions, Inc. (Z-1387-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79378/
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