Cold Storage Solution — Class II medical device recall Z-1387-2018
Terminated recall by Preservation Solutions, Inc., reported 2018-04-25. Bags of solution may have a small leak at the base of the injection port where the port is welded into the bod
| Recall number | Z-1387-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preservation Solutions, Inc., Elkhorn, WI, United States |
| Recall initiated | 2018-02-26 |
| Classified | 2018-04-16 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2022-09-09 |
| Quantity | 31,104 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00810805000071, 00810805000163 |
| Model numbers | CSS/2000/US |
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.
Reason for recall
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..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1387-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.