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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 for
Recalled October 19, 2016 · FDA recall Z-0068-2017 · Surgical Specialties Mexico S DE RL DE CV
Hazard
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package. · FDA Class II
Units
512 boxes (2560 units)
Sold at
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,
Description
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
Product
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Manufacturer(s)
Surgical Specialties Mexico S DE RL DE CV
Made in
Mexico
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →