The units should be thawed in a manner that has been established as appropriate for the overall preservation technique.
Infusion documentation shall facilitate tracking of the product from the donor to recipient. A component infusion form shall be issued with the product and completed for each component infused. A copy should be returned to the processing laboratory.
There must be an effective recall procedure in place defining responsibilities and actions to be taken including notification to the Competent Authority (HTA).
Procedures must be in place for the documentation of returned products, defining acceptance criteria into the inventory.