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Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns
Integra LifeSciences is recalling MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfer documentation, both of which help ensure the products were effectively sterilized.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact their Integra Sales Representative or Customer Service at 1-800-654-2873 or custsvcnj@integralife.com.
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