Reported May 5, 2021 · Ongoing
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Colpassist Vaginal
- Positioning Device - Product Usageintended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
- Lot codes and dates
- All unexpired lotsGTIN 08714729848097
C003699C003715C003735C003750C003775C003804C003813C003842C003853C003887C003905C003936C003950C003960C003966C003986C003997C004028C004041C004078C004091C004107C004117C004128C004136C004160C004186C004206C004221
- All unexpired lots
- Amount recalled
- 4,549 WW
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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