Device 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.
Z-1387-2018
Product summary
- Event
- Event 79378
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,104 units
- Official record key
device-enforcement:Z-1387-2018
Official wording
Reason: 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..
Code information: UDI 00810805000163, and UDI 00810805000071.
Distribution pattern: Worldwide Distribution -- USA and Europe.
Derived failure modes
-
Unknown
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..