FIVE S 3.5X65, STERILE FOR SINGLE USE

For products affected, the required sterility assurance level was not achieved during recent testing of the sterilization process performed by the contract sterilizer. The testing was initiated as a result of a regular re-qualification review. The affected products therefore may not be "sterile" as claimed. Recall start date: 2021-08-09

Lack of efficacy

FIVE S 3.5X65, STERILE FOR SINGLE USE

RA-63610