FDA-Device2016-10-19Class II
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
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.
Sold states
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,
Affected count
512 boxes (2560 units)
Manufactured in
Corredor Tijuana - Rosarito 2000-24702 B, Ejido Francisco Villa, Tijuana, N/A, Mexico
Products
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2017Don't want to check this manually?
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