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

Recall date

February 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1621-2018

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

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,…

Why it was recalled

Potential for Capio sutures to break and /or detach.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.