Boston Scientific Corporation recalls Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Recalled May 16, 2018 · FDA recall Z-1618-2018 · Boston Scientific

Hazard

Potential for Capio sutures to break and /or detach. · FDA Class II

Units

1,258

Sold at

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

Description

Potential for Capio sutures to break and /or detach.

Product

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →