Boston Scientific Corporation recalls Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the

Recalled May 16, 2018 · FDA recall Z-1621-2018 · Boston Scientific

Hazard

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

Units

2,567

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 RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.

Manufacturer(s)

Boston Scientific Corporation

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