FDA-Device2018-04-25Class II
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.
Preservation Solutions, Inc.
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..
Sold states
Worldwide Distribution -- USA and Europe.
Affected count
31,104 units
Manufactured in
1099 Proctor Dr, Elkhorn, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1387-2018Don't want to check this manually?
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