Events

Recall of BioSentry" Tract Sealant System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Surgical Specialties Mexico S DE RL DE CV.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75273
  • Event Risk Class
    Class 2
  • Event Number
    Z-0068-2017
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149916
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Absorbable lung biopsy plug - Product Code OMT
  • Reason
    Surgical specialties mexico is recalling the biosentry track sealant system due to the potential for an open seal on the product package.
  • 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.

Device

BioSentry" Tract Sealant System
  • Model / Serial
    MAWX380, MAZD460, MAZR350, MBCF540
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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,
  • Product Description
    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
  • Manufacturer
    Surgical Specialties Mexico S DE RL DE CV

Manufacturer

Surgical Specialties Mexico S DE RL DE CV
  • Manufacturer Address
    Surgical Specialties Mexico S DE RL DE CV, Corredor Tijuana - Rosarito 2000-24702 B, Ejido Francisco Villa, Tijuana Mexico
  • Manufacturer Parent Company (2017)
    Angiotech Pharmaceuticals, Inc.
  • Source
    USFDA