Reported Apr 25, 2018 · Terminated
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold…
Preservation Solutions, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Preservation Solutions, Inc. · 1099 Proctor Dr · Elkhorn, WI · 53121-2027
Is this the product you have?
- 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.
- Lot codes and dates
UDI 00810805000163and UDI 00810805000071
- Amount recalled
- 31,104 units
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..
This product could cause temporary or reversible health problems — stop using it.
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