Z-0068-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- September 24, 2016
- Termination Date
- December 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 512 boxes (2560 units)
Product Description
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Reason for Recall
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
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,
Code Information
MAWX380, MAZD460, MAZR350, MBCF540