Device product
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Z-0068-2017
Product summary
- Event
- Event 75273
- Status
- Terminated
- Classification
- Class II
- Quantity
- 512 boxes (2560 units)
- Official record key
device-enforcement:Z-0068-2017
Official wording
Reason: Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
Code information: MAWX380, MAZD460, MAZR350, MBCF540
Distribution pattern: 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,
Derived failure modes
-
Labeling or packaging
open seal