Z-1491-2021 Class II Ongoing
Recalled by Boston Scientific Corporation
— Marlborough, MA
FDA device recall Z-1491-2021 was initiated by Boston Scientific Corporation on April 15, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 8,524 WW.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- April 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,524 WW
Product Description
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 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.
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 Pattern
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.
Code Information
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