Preservation Solutions, Inc. recalls Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold St…

Recall date

February 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1387-2018

FDA classification

Class II

Brand / firm

Preservation Solutions, Inc.

Sold / distributed

Worldwide Distribution -- USA and Europe.

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..

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.