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Boston Scientific Corporation recalls Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assis
Recalled May 16, 2018 · FDA recall Z-1617-2018 · Boston Scientific
Hazard
Potential for Capio sutures to break and /or detach. · FDA Class II
Units
60,538
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 Box 5, Model #M0068318261; 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 →