A review of complaints on Sureform PNs 480445, 480545, 480460 was done to determine rate of harm due to tissue pushout events. This action was completed as part of an internal capa. Sureform complaint data from October 1, 2019 through September 30, 2021 was reviewed. Overall rate of harm associated with bleeding (tissue pushout events) of critical severity exceeds the predicted likelihood of harm as documented. Recall start date: Mar 17, 2022
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