BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Class I - Dangerous 🏥 Medical Devices
Recalled: September 24, 2016 Surgical Specialties Mexico S DE RL DE CV Surgical Instruments
Nationwide
What Should You Do?
- Check if you have this product: MAWX380, MAZD460, MAZR350, MBCF540
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Surgical Specialties Mexico S DE RL DE CV
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Product Codes/Lot Numbers:
MAWX380, MAZD460, MAZR350, MBCF540
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0068-2017