On July 31, 2024, Merit internally identified an issue related to potential holes being found in the Tyvek® sterile barrier of certain MONARCH® inflation devices during the manufacture of lot H3003824. Visual inspection of the packaged units from lot H3003824 found a potential hole in 28 of 776 manufactured units. The 28 units underwent a bubble test where 23 of the 28 units failed, confirming a hole in the sterile barrier. Further investigation has determined that certain placements of the MONARCH® inflation device within a rigid formed blister tray can cause a hole in the Tyvek®. Should a MONARCH® inflation device's placement result in the unit's retainer cap being positioned above the rigid blister flange, the Tyvek® can contact a multivac's cross-cut station potentially leading to an abrasion or hole in the Tyvek®. Recall start date: August 28, 2024
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