Preservation Solutions Recalls Cold Storage Solution Bags Due to Leaks
Preservation Solutions, Inc. is recalling 31,104 units of Cold Storage Solution bags due to potential leaks at the injection port.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, and the defect is a small leak rather than a structural failure or contamination, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Preservation Solutions, Inc. is recalling 31,104 units of 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). The affected products are intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation. The recall was initiated because bags of the solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.
The affected units were distributed worldwide, including in the USA and Europe. The specific units are identified by UDI 00810805000163 and UDI 00810805000071. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities and distributors should stop using the affected Cold Storage Solution bags and contact Preservation Solutions, Inc. for further instructions on the recall.
The recalled product
- 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 tra
- Manufacturer
- Preservation Solutions, Inc.
- Hazard
- Affected units
- 31,104
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 00810805000163
- and UDI 00810805000071.
Distribution
Distribution scope not specified by the agency.
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