| Class 2 Device Recall BioSentry" Tract Sealant System |  |
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 |
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
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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 |
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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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