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Z-0068-2017 Class II Terminated

Recalled by Surgical Specialties Mexico S DE RL DE CV — Tijuana, N/A

FDA device recall Z-0068-2017 was initiated by Surgical Specialties Mexico S DE RL DE CV on September 24, 2016 and is designated Class II. 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. The recall status is terminated (terminated December 6, 2016). Affected quantity: 512 boxes (2560 units).

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