UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended 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 impacte
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling the UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device, which is used as a bridging material during sacrocolposuspension and sacrocolpopexy surgical procedures. The recall affects 8,524 units distributed worldwide, including nationwide distribution in the United States and distribution to numerous other countries. The devices have a potential defect where pinholes may form in the sterile barrier on the edge of the pouch, which could compromise sterilization and potentially result in post-operative infection.
The recall includes all unexpired lots from lot codes C003726 through C004223. The GTIN for the affected product is 08714729848103. The source document does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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, Sloveni Quantity: 8,524 WW Lot/code info: All unexpired lots: C003726 C003737 C003739 C003752 C003767 C003778 C003782 C003791 C003814 C003818 C003831 C003845 C003846 C003874 C003875 C003898 C003899 C003921 C003942 C003954 C003970 C003988 C003989 C003999 C004000 C004011 C004012 C004031 C004032 C004033 C004048 C004049 C004084 C004085 C004086 C004097 C004098 C004099 C004120 C004132 C004143 C004150 C004159 C004175 C004176 C004196 C004205 C004213 C004218 C004223 GTIN: 08714729848103
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.