Medical device recalls Moderate risk

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

Recall date
February 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1618-2018
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 CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

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