Belzer UW Cold Storage Solution recallZ-1387-2018 · Preservation Solutions, Inc. · initiated Feb 26, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Preservation Solutions, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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..
FDA root cause category: Nonconforming Material/Component
What the company is doing
An Urgent: Product Recall Notification letters, dated February 26, 2018, were sent to consignees. The instructions include, halting distribution of any 2 Liter bags in inventory; and, arranging for the return of affected units. Preservation Solutions, Inc. provided a notification letter for their consignees to provide to their customers. The letter instructed customers to return any 2 Liter bags to their supplier, and to complete and return the acknowledgement form.
Recall details
- Recall number
- Z-1387-2018
- Status
- Terminated
- Initiated by the company
- Feb 26, 2018
- Recalling firm
- Preservation Solutions, Inc.
- Quantity
- 31,104 units
- Product code
- KDN
- FDA submissions
- K073693
- Distribution
- Worldwide Distribution -- USA and Europe.
Product description
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.
Code information (models, lots, serial numbers)
UDI 00810805000163, and UDI 00810805000071.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Belzer UW Cold Storage Solution BUW-002Preservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
- Waters IGL Cold Storage Solution CSS/2000/USPreservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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