Boston Scientific Corporation recalls Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open

Recalled May 16, 2018 · FDA recall Z-1616-2018 · Boston Scientific

Hazard

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

Units

21,250

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 SLIM Suture Capturing Device, Model #M0068318250. 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 →