Reported May 5, 2021 · Ongoing
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging…
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?
- UpsylonTM Y Mesh Kit with Colpassist Vaginal
- Positioning Device - Product Usageintended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal
- NoteThe UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed
- Lot codes and dates
- All unexpired lots
C003726C003737C003739C003752C003767C003778C003782C003791C003814C003818C003831C003845C003846C003874C003875C003898C003899C003921C003942C003954C003970C003988C003989C003999C004000C004011C004012C004031C004032C004033C004048C004049C004084C004085C004086C004097C004098C004099C004120C004132C004143C004150C004159C004175C004176C004196
- C004205 C004213 C004218 C004223 GTIN08714729848103
- All unexpired lots
- Amount recalled
- 8,524 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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