Z-1387-2018Class II

Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer...

Name: Z-1387-2018 Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer...
Creator: Preservation Solutions, Inc.
Published: 2018-02-26
License: https://open.fda.gov/license/

Preservation Solutions Inc / initiated 2018-02-26 / Terminated / root cause: manufacturing process

FDA source

Preservation Solutions, Inc. began a recall of 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... on 2018-02-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1387-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-26
Posted: 2018-04-16
Terminated: 2022-09-09
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.
Product code: KDN System, Perfusion, Kidney
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..
Root cause tag: manufacturing process
FDA 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 in commerce: 31,104 units
Distribution: Worldwide Distribution -- USA and Europe.
Product codes and lots: UDI 00810805000163, and UDI 00810805000071.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1387-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1387-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-16

Product code KDN

K073693Class IICostorsolPreservation Solutions, Inc. / cleared 2008-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)