Home / Recalls / Preservation Solutions, Inc. / Z-1387-2018

Z-1387-2018 Class II Terminated

Recalled by Preservation Solutions, Inc. — Elkhorn, WI

Recall Details

Product Type: Devices
Report Date: April 25, 2018
Initiation Date: February 26, 2018
Termination Date: September 9, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 31,104 units

Product Description

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.

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..

Distribution Pattern

Worldwide Distribution -- USA and Europe.

Code Information

UDI 00810805000163, and UDI 00810805000071.