Recall Z-1490-2021— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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.
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-04-15
- Firm location
- Marlborough, MA, United States
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.