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.
FDA Recall Z-1387-2018 · Posted None
Recalling FirmPreservation Solutions, Inc.
Recall StatusTerminated
Product CodeKDN
Date Initiated2018-02-26
Date Terminated2022-09-09
Product Quantity31,104 units
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..
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- USA and Europe.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.