Reported Oct 19, 2016 · Terminated
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location…
Surgical Specialties Mexico S DE RL DE CV
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Surgical Specialties Mexico S DE RL DE CV · Corredor Tijuana - Rosarito 2000-24702 B · Tijuana, N/A · N/A
Is this the product you have?
- BioSentry Tract Sealant System
- Product Code768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection
- Lot codes and dates
MAWX380MAZD460MAZR350MBCF540
- Amount recalled
- 512 boxes (2560 units)
Where it was sold
Why it was recalled
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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