Recall Z-0068-2017— Surgical Specialties Mexico S DE RL DE CV
Class II · Terminated
Class II FDA medical device recall by Surgical Specialties Mexico S DE RL DE CV, initiated 2016-09-24, terminated 2016-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.. Reason: Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package..
- Recalling firm
- Surgical Specialties Mexico S DE RL DE CV
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-24
- Terminated
- 2016-12-06
- Firm location
- Tijuana, N/A, Mexico
Product description
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.