Davol, Inc. is recalling 1,622 units of Avitene Ultrafoam Microfibrillar Collagen Hemostat, a surgical sponge used to control bleeding, because the product may contain foreign matter identified as insect fragments. No injuries or incidents have been reported to date regarding this contamination. This recall affects worldwide distribution including hospitals and healthcare facilities across the United States, China, and South Korea.
The presence of insect fragments in a sterile surgical hemostat can introduce biological contaminants into a patient's body during surgery, potentially leading to serious infections or inflammatory reactions.
UDI: (01)00801741010538(17)270728(10)WBJS0055
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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