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
Reported: May 5, 2021 Initiated: April 15, 2021 #Z-1490-2021
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
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 4,549 WW
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Boston Scientific Corporation. Units affected: 4,549 WW.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 5, 2021. Severity: Moderate. Recall number: Z-1490-2021.
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