Surgical Specialties Recalls BioSentry Tract Sealant System Due to Packaging Defect
Surgical Specialties Mexico is recalling the BioSentry Tract Sealant System because the product packages may have open seals.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging defect (open seal) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Surgical Specialties Mexico S DE RL DE CV is recalling the BioSentry Tract Sealant System, Product Code 768022019S. The recall is due to the potential for an open seal on the product package. The affected product is indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
The recall involves 512 boxes (2,560 units) of the BioSentry Tract Sealant System. The affected units were distributed in the United States to the states of Ohio, Pennsylvania, Colorado, Massachusetts, Delaware, California, New York, Virginia, Washington, New Jersey, Connecticut, Florida, Texas, New Hampshire, Idaho, Oklahoma, Arizona, Georgia, and Nevada, as well as Vermont. The product was also distributed worldwide to Spain, Italy, the United Kingdom, Portugal, Turkey, Germany, and Denmark. The affected lot codes are MAWX380, MAZD460, MAZR350, and MBCF540.
Healthcare providers and consumers should stop using the BioSentry Tract Sealant System if it matches the affected product code and lot codes listed above. Users should contact Surgical Specialties Mexico for further instructions on how to return or dispose of the product.
The recalled product
- Product
- BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
- Manufacturer
- Surgical Specialties Mexico S DE RL DE CV
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- MAWX380
- MAZD460
- MAZR350
- MBCF540
Distribution
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