Failed sterilisation of container lids

Record number: 
MPHO Type: 
Alerting signals, symptoms, evidence of occurrence: 
Detection of a failure in the sterilization process of rubber stoppers for cornea vials. The indicator for sterilization did not change in color and was detected after some corneas had already been released. Several tissues had to be recalled.
Demonstration of imputability or root cause: 
Identified by the Tissue Bank