Surgical Specialties Mexico S DE RL DE CV recalls BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location fo…

Recall date

September 24, 2016

Source

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

Recall number

Z-0068-2017

FDA classification

Class II

Brand / firm

Surgical Specialties Mexico S DE RL DE CV

Sold / distributed

US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT. Worldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,

Why it was recalled

Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.

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

What was recalled

BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.