Recall Z-1490-2021 — Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
U.S. FDA — Device Enforcement · United States · 2021-04-15 · Class II
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Reported risk: Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
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