FDA Device recall Z-1387-2018
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US by Preservation Solutions, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1387-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-26 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Preservation Solutions |
| Distribution | n/a |
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
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..
Identifiers
| code_info | UDI 00810805000163, and UDI 00810805000071. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1387-2018%22
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