Recall Z-0068-2017 ยท OMT Absorbable Lung Biopsy Plug
Surgical Specialties Mexico S DE RL DE CV
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
| Date | Sep 24, 2016 |
| Status | Terminated |
| Reason | Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package. |
| 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 kknappenberger@surgicalspecialties.com. Customers with questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.