Home / Recalls / Medical Devices
Preservation Solutions, Inc. recalls Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Sto
Recalled April 25, 2018 · FDA recall Z-1387-2018 · Preservation Solutions
Hazard
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.. · FDA Class II
Units
31,104 units
Sold at
Worldwide Distribution -- USA and Europe.
Description
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..
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.
Manufacturer(s)
Preservation Solutions, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →