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U.S. Department of Health and Human Services

Class 2 Device Recall BioSentry" Tract Sealant System

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  Class 2 Device Recall BioSentry" Tract Sealant System see related information
Date Initiated by Firm September 24, 2016
Create Date October 11, 2016
Recall Status1 Terminated 3 on December 06, 2016
Recall Number Z-0068-2017
Recall Event ID 75273
510(K)Number K082438  
Product Classification Absorbable lung biopsy plug - Product Code OMT
Product BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Code Information MAWX380, MAZD460, MAZR350, MBCF540
Recalling Firm/
Manufacturer		 Surgical Specialties Mexico S DE RL DE CV
Corredor Tijuana - Rosarito 2000-24702 B
Ejido Francisco Villa
Tijuana Mexico
For Additional Information Contact Kristine Liberacki
262-994-8083
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action An Urgent Product Recall Notification Letter dated 9/24/16 was sent to customers to inform them that Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package. The letter informs the customers to complete the customer acknowledgement form and return via fax to their quality assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com. Customers with questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.
Quantity in Commerce 512 boxes (2560 units)
Distribution 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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