Recall Z-1491-2021 ยท OHD Gynecological Laparoscopic Kit
Boston Scientific Corporation
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 impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vag
| Date | Apr 15, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Packaging process control |
| Action | Boston Scientific issued Urgent Medical Device Product Removal on 4/15/21 via FedX. Letter states reason for recall, health risk and action to take; Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. This removal affects only the UPNs and batches listed below and in Attachment 1. No other UPNs or batches are impacted by this removal. Please cease further distribution or use of any remaining product affected by this removal immediately. If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately |
| Quantity | 8,524 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.