FDA Medical Device Recalls (openFDA)
Preservation Solutions, Inc.: 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.
- Recall number
- Z-1387-2018
- Recalling firm
- Preservation Solutions, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-02-26
- Posted
- not on file
- Terminated
- 2022-09-09
- 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..
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 31,104 units
- Distribution
- Worldwide Distribution -- USA and Europe.
- Lot, serial or model codes
- UDI 00810805000163, and UDI 00810805000071.
- 510(k) numbers
- ["K073693"]
- PMA numbers
- not on file
- Product code
- KDN
- Firm FEI
- 1000221028
- Firm city
- Elkhorn
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28