Z-0068-2017Class II

BioSentry Tract Sealant System

Name: Z-0068-2017 BioSentry Tract Sealant System
Creator: Surgical Specialties Mexico S DE RL DE CV
Published: 2016-09-24
License: https://open.fda.gov/license/

Surgical Specialties Mexico S de RL de CV / initiated 2016-09-24 / Terminated / root cause: manufacturing process

FDA source

Surgical Specialties Mexico S DE RL DE CV began a recall of BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection on 2016-09-24. FDA classified it as Class II and gives the reason as "Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0068-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-24
Posted: 2016-10-11
Terminated: 2016-12-06
Recalling firm: Surgical Specialties Mexico S de RL de CV
Product: BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Product code: OMT Absorbable Lung Biopsy Plug
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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,
Product codes and lots: MAWX380, MAZD460, MAZR350, MBCF540

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0068-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0068-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-11

Product code OMT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)