medical Class II Updated 2018-04-25

Preservation Solutions, Inc. recalls Cold Storage Solution, 2L, labeled as Waters IGL Cold Storag

Recalled 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.

Hazard / Issue

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..

Issued by

FDA

Distribution: Worldwide Distribution -- USA and Europe.
Lot/Code Info: UDI 00810805000163, and UDI 00810805000071.
View official government recall

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